2,153 Clinical Development Director jobs in the United States
Clinical Scientist, Director Clinical Development
07054 Parsippany, New Jersey
Teva Pharmaceuticals
Posted 12 days ago
Job Viewed
Job Description
Clinical Scientist, Director Clinical Development
Date: Sep 26, 2025
Location:
Parsippany, United States, New Jersey, 07055
Company: Teva Pharmaceuticals
Job Id: 64219
**Who we are**
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
**The opportunity**
The Clinical Scientist (CS), Director provides scientific expertise necessary to design and deliver clinical studies and is responsible for clinical activities of assigned program. This role partners closely with the disease area heads, clinical trial physician, and clinical lead, in developing the scientific and clinical strategy of assigned trials and/or programs. As part of the clinical development team, the CS will use methodological, analytical and scientific expertise to develop study designs in different phases of clinical development. The CS ensures the collection, analysis, review, and reporting of high-quality trial data in accordance with Clinical Development plans. The role requires a well-organized operationally focused individual with analytic skills and ability to deliver multiple tasks that can collaborate closely with cross-functional teams. The CS is a member of the study team and CDT.
The role of the Clinical Scientist is to:
+ Provide scientific expertise to the clinical studies (eg: protocol, Key Results, Clinical Study Report)
+ Leads, plans and executes study level activities for one or more trials with minimal supervision
+ Support other clinical development activities (e.g. medical review and validation of clinical data, study risk assessment)
+ Contribute to the Protocol concept sheet, final protocol and protocol amendments and the clinical study report for their study(ies)
+ Contribute to the clinical part of regulatory documents for their projects: Common Technical Document for FDA & EMA submission, PMDA, CA, etc and answers to questions from health authorities
+ Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, clinical development team, and Investigators
+ Be the clinical reference in the Clinical Study team related to clinical data
This role can be based in the Parsippany, NJ or the West Chester, PA locations.
**How you'll spend your day**
+ Support the development of the protocol concept sheet, final protocol and protocol amendments.
+ Contribute to the development, writing and review of the Clinical Development Plan (CDP).
+ Provide appropriate medical input & support for all activities related to clinical studies such as medical training, site feasibility, and medical information to the study team, clinical development team, and investigators.
+ Activities related to data generation and validation, including CRF (case report form) design, clinical data review/query resolution. Ensure continuous medical review of aggregated data during clinical trial conduct to identify trends and ensure quality data for database locks and interim cuts.
+ Author or contribute to the development or review of medical related study documents (pre-defined protocol deviation list, the Informed Consent Form, narrative plan, study specific committee charter, etc).
+ Support CRAs/CROs on study protocol and related questions and serves as a point of contact for managing/answering questions relating to trial procedures.
+ Engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
+ Assist in the processing of responses to medical questions raised by EC/IRBs, sites.
+ Review development of site and CRA training materials and presentation at site initiation visit and Investigator meetings and support on Study committee (e.g., DMC, protocol review committee).
+ Support clinical aspects of Business Development and Licensing activities as needed.
**Your experience and qualifications**
+ Advanced Degree required preferably in Life Sciences (MD, PhD, Pharm D, MS, RN or another scientific field preferred). Strong scientific background is required.
+ A minimum of 5 years of experience in clinical development within pharmaceutical industry or CRO, specifically in clinical study design, data analysis, data review and interpretation is required.
Functional Knowledge:
+ Understanding of phase I-III drug development including knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development processes.
+ Demonstrates knowledge and application of statistical analysis methodology and can identify data trends and interpret data effectively through the continuum of a study.
+ Knowledge of Therapeutic Area (TA) preferred, with the capability to interpret, discuss and present trial or program level data.
+ Maintain knowledge of the TA, disease state and potential drug effects
Job-Specific Competencies:
+ Excellent scientific communication skills, both verbal and in writing (English).
+ Ability to communicate effectively with senior management and colleagues.
+ Strong negotiation and conflict resolution skills.
+ Strong presentation skills.
+ Ability to work in a matrix organization environment.
+ Highly self-motivated and proactive.
+ Team player.
Travel for the role is expected to be less the 20%
**Compensation Data**
The annual starting salary for this position is between $227,000 - 297,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.
**Enjoy a more rewarding choice**
Enjoy a more rewarding choice
+ We offer a competitive benefits package, including:
+ Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
+ Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
+ Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
+ Life and Disability Protection: Company paid Life and Disability insurance.
+ Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
**Already Working @TEVA?**
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site ( internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
**Teva's Equal Employment Opportunity Commitment**
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.
**Important notice to Employment Agencies - Please Read Carefully **
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
EOE including disability/veteran
Date: Sep 26, 2025
Location:
Parsippany, United States, New Jersey, 07055
Company: Teva Pharmaceuticals
Job Id: 64219
**Who we are**
Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
**The opportunity**
The Clinical Scientist (CS), Director provides scientific expertise necessary to design and deliver clinical studies and is responsible for clinical activities of assigned program. This role partners closely with the disease area heads, clinical trial physician, and clinical lead, in developing the scientific and clinical strategy of assigned trials and/or programs. As part of the clinical development team, the CS will use methodological, analytical and scientific expertise to develop study designs in different phases of clinical development. The CS ensures the collection, analysis, review, and reporting of high-quality trial data in accordance with Clinical Development plans. The role requires a well-organized operationally focused individual with analytic skills and ability to deliver multiple tasks that can collaborate closely with cross-functional teams. The CS is a member of the study team and CDT.
The role of the Clinical Scientist is to:
+ Provide scientific expertise to the clinical studies (eg: protocol, Key Results, Clinical Study Report)
+ Leads, plans and executes study level activities for one or more trials with minimal supervision
+ Support other clinical development activities (e.g. medical review and validation of clinical data, study risk assessment)
+ Contribute to the Protocol concept sheet, final protocol and protocol amendments and the clinical study report for their study(ies)
+ Contribute to the clinical part of regulatory documents for their projects: Common Technical Document for FDA & EMA submission, PMDA, CA, etc and answers to questions from health authorities
+ Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, clinical development team, and Investigators
+ Be the clinical reference in the Clinical Study team related to clinical data
This role can be based in the Parsippany, NJ or the West Chester, PA locations.
**How you'll spend your day**
+ Support the development of the protocol concept sheet, final protocol and protocol amendments.
+ Contribute to the development, writing and review of the Clinical Development Plan (CDP).
+ Provide appropriate medical input & support for all activities related to clinical studies such as medical training, site feasibility, and medical information to the study team, clinical development team, and investigators.
+ Activities related to data generation and validation, including CRF (case report form) design, clinical data review/query resolution. Ensure continuous medical review of aggregated data during clinical trial conduct to identify trends and ensure quality data for database locks and interim cuts.
+ Author or contribute to the development or review of medical related study documents (pre-defined protocol deviation list, the Informed Consent Form, narrative plan, study specific committee charter, etc).
+ Support CRAs/CROs on study protocol and related questions and serves as a point of contact for managing/answering questions relating to trial procedures.
+ Engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
+ Assist in the processing of responses to medical questions raised by EC/IRBs, sites.
+ Review development of site and CRA training materials and presentation at site initiation visit and Investigator meetings and support on Study committee (e.g., DMC, protocol review committee).
+ Support clinical aspects of Business Development and Licensing activities as needed.
**Your experience and qualifications**
+ Advanced Degree required preferably in Life Sciences (MD, PhD, Pharm D, MS, RN or another scientific field preferred). Strong scientific background is required.
+ A minimum of 5 years of experience in clinical development within pharmaceutical industry or CRO, specifically in clinical study design, data analysis, data review and interpretation is required.
Functional Knowledge:
+ Understanding of phase I-III drug development including knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development processes.
+ Demonstrates knowledge and application of statistical analysis methodology and can identify data trends and interpret data effectively through the continuum of a study.
+ Knowledge of Therapeutic Area (TA) preferred, with the capability to interpret, discuss and present trial or program level data.
+ Maintain knowledge of the TA, disease state and potential drug effects
Job-Specific Competencies:
+ Excellent scientific communication skills, both verbal and in writing (English).
+ Ability to communicate effectively with senior management and colleagues.
+ Strong negotiation and conflict resolution skills.
+ Strong presentation skills.
+ Ability to work in a matrix organization environment.
+ Highly self-motivated and proactive.
+ Team player.
Travel for the role is expected to be less the 20%
**Compensation Data**
The annual starting salary for this position is between $227,000 - 297,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.
**Enjoy a more rewarding choice**
Enjoy a more rewarding choice
+ We offer a competitive benefits package, including:
+ Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
+ Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
+ Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
+ Life and Disability Protection: Company paid Life and Disability insurance.
+ Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.
**Already Working @TEVA?**
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site ( internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
**Teva's Equal Employment Opportunity Commitment**
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.
**Important notice to Employment Agencies - Please Read Carefully **
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
EOE including disability/veteran
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0
Clinical Trials Assistant
89105 North Las Vegas, Nevada
CovarsaDx
Posted today
Job Viewed
Job Description
Job Title: Clinical Trials Assistant
Location: On-Site / Henderson, Las Vegas
Department: Clinical Operations
Reports To: Clinical Operations Associate
Job Type: Full-time
Salary Range: $50,000-$65,000 annually. Compensation offered will reflect the skills and experience of the candidate.
Classification: Non-exempt (overtime eligible)
About us:
CovarsaDx is a clinical research organization (CRO) that is dedicated to clinical studies for IVD (in vitro diagnostic) and medical device trials. Our clients experience personalized study strategies, expert consultation, and agile adaptation to changing trial design requirements. We prioritize our clients' regulatory success and clinical research experience, supported by trusted clinical research specialists and resources.
Position Description:
The Clinical Trials Assistant will play a key role in supporting clinical trial operations by assisting with site selection processes, coordinating logistics, and managing administrative tasks. This role requires strong organizational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment. The ideal candidate will have experience in clinical research, healthcare, or logistics, with a proactive approach to problem-solving and process improvement.
Key Responsibilities:
Site Selection & Clinical Operations Support
· Assist in tracking and managing site feasibility assessments and qualification processes.
· Maintain and update site databases, ensuring accurate documentation and record-keeping.
· Coordinate communication between internal teams, sponsors, and investigative sites.
· Support site selection strategies by compiling reports and summarizing key site metrics.
· Assist with the collection and filing of site and study documents for Trial Master Files.
Logistics & Administrative Coordination
· Manage shipping, tracking, and inventory of study-related materials, supplies, and investigational
products.
· Track and manage shipments, providing updates to internal teams and investigative sites.
· Ensure timely documentation and compliance with study protocols and regulatory requirements.
· Support the preparation and coordination of study materials
· Maintain SOPs, study trackers, and administrative records to support clinical trial operations.
Additional Responsibilities
This job description is intended to outline the primary responsibilities of the Clinical Trials Assistant; however, additional duties and tasks may be assigned as needed to support the clinical trial process. These additional responsibilities are not limited to the above and may evolve over time based on the requirements of the study or operational needs.
Competencies
· Communication and Interpersonal Skills – Excellent written and verbal communication skills with study
teams, participants, and internal / external stakeholders.
· Time and Prioritization Management – Strong organizational skills, with ability to manage multiple
tasks and prioritize effectively in a fast-paced environment.
· Attention to Detail – Strong attention to detail to keep detailed, accurate records and ensure all
protocol requirements and regulations are strictly followed.
· Collaboration and Cross-Functional Coordination – The ability to work independently and to work with
various groups to support documentation needs and ensure alignment and collaboration with cross-
functional teams.
· Problem-solving Mindset - The ability to anticipate needs to address issues proactively. Must possess
analytical and creative thinking skills.
· Operational Efficiency – Strong time management skills, able to use time productively to ensure high
levels of operational efficiency and effectiveness.
· Confidentiality – Able to maintain strict confidentiality in handling sensitive participant data and study-
related information.
· Technical Proficiency – Competence using common business software such as MSOffice (Word, Excel,
PowerPoint, Outlook, Teams) and Adobe Acrobat and study-specific tools or software.
Minimum Qualifications
· Bachelor's degree in a scientific, healthcare-related or business management or related field.
· Minimum two years’ experience in an administrative or logistics role (preferably in clinical research,
healthcare, or a regulated industry).
Preferred Qualifications
· Prior experience working in clinical trial administration, site selection, or study logistics.
· Certifications such as Good Clinical Practice (GCP), Dangerous Goods Regulation (DGR) Training,
and/or HIPPA Certification.
· Previous work in a Contract Research Organization (CRO), IVD and Medical Device Trials.
Work Environment / Physical Demands
· Onsite office position
· Appropriate availability consistent with established practices and norms; effort may exceed 40 hours
per week when required to meet critical deadlines.
· Ability to sit and/or stand to work at a computer for extended periods of time.
· Ability to lift and move up to 10 pounds.
Featured Benefits:
- Medical insurance
- Vision insurance
- Dental insurance
- 401K Plan and company match
We are proud to be an equal opportunity employer. We select and employ candidates only in accordance with their merits, qualifications, and abilities to perform the duties of the job regardless of gender, marital status, race, religion, color, age, disability, sexual orientation, military or veteran status. If you require an accommodation as part of the application and/or interview process, please contact .
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1
Clinical Trials - Clinical Data Associate
46202 Indianapolis, Indiana
Lilly
Posted 2 days ago
Job Viewed
Job Description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges.
***Please note, this is a hybrid position 3 days onsite/2 days remote***
**Purpose:**
This role is responsible for trial level clinical data strategy including database structure, content and meaning, acquisition, storage, retrieval, interchange, delivery and representation. This requires an in depth understanding of data collection, data flow management, data quality, data technology, dataset delivery, archiving and data standards. This role will collaborate with key study partners to define, implement, and deliver clinical data management packages. This role is responsible for providing trial leadership and ownership for a particular trial, set of trials, or programs.
**Primary Responsibilities:**
**Portfolio Strategy, Planning and Delivery**
+ Define Lilly business requirements for the study/program for vendors to deliver
+ Ensure that data management timeline and results are delivered to scope, cost, and time objectives
+ Perform project monitoring and quality oversight of sourcing providers for end-to-end data management activities - from study set up through trial execution through dataset delivery
+ Ensure vendor performance for the program-level flow of data, including across niche vendors and niche data sources (pharmacokinetic, immunogenicity, biomarker)
+ Drives data flow design through consultation, review, and approval of vendor work. Ensures the data flow design is aligned with the project hypothesis
+ Approve key outputs and results (i.e. Data Quality Delivery Plan, Data lock Plan, Project Plan, database, and observed datasets)
+ Define and approve data quality and submission outputs and results
**Project Management**
+ Ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives
+ Specifies the data collection tools and technology platforms for the trial/program
+ Drive standards decisions, implementation and compliance for the study/program
+ Help create scope scenarios and negotiate outcomes with study teams while taking into account the cost and value of scenarios
+ Facilitate/assimilate integration of disparate data sources into datasets for decision making
+ Use therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate
+ Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables
**Communication**
+ Act as primary communication point for all data management activities related to a clinical study.
+ Report out status of data management milestones and data quality.
+ Partner with external data vendors: understand specifications to import multiple types of data, work with technical groups to ensure timely loads of external data sets into the sponsor's database.
+ Demonstrate excellent written and verbal communication skills, including the ability to represent the Data and Analytics organization and influence stakeholders to drive data-driven decisions.
+ Partner with cross-functional team members to ensure trial success through robust oversight/review.
**Process Improvement**
+ Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
+ Represent data sciences' processes in multi-functional initiatives.
+ Actively engage in shared learning across the Data and Analytics organization.
+ Work with partners to increase vendor/partner efficiencies
**Minimum Qualification Requirements:**
+ Master's degree in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences (or Bachelor's degree plus 3 or more years of experience in clinical data management or areas that closely intersect with clinical data management e.g., statistics, data analytics, information technology, health outcomes, etc.)
**Other** **Information/Additional** **Preferences:**
+ Demonstrated ability to set and implement plans to improve complex clinical data management processes and capabilities
+ Demonstrated ability to effectively partner/influence a remote team and drive a technical project to deliver results
+ Experience with application of clinical data management skills such as data flow, data quality & integrity, data interchange, data mining, and data representation principles
+ Demonstrated ability to lead development of creative data solutions to address clinical development challenges
+ Passionate about improving technological solutions using new technologies
+ Society of Clinical Data Management certification
+ Working knowledge of programming languages & Industry tools such as Tableau, PowerBI, Python, SAS, 'R' and Shiny for reporting, metrics and visualizations along with P-SQL, T-SQL for DBMS.
+ Experience with the following:
+ Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions
+ Utilization of clinical/drug development knowledge and an ability to collaborate closely effectively with study team members (i.e. Statistics, PK, Operations, Medical)
+ Strong therapeutic/scientific knowledge in the field of research
+ Knowledge of medical terminology
+ Domestic and International travel may be required
+ Ability to balance multiple activities, prioritize and manage ambiguity
+ Demonstrated exemplary teamwork/interpersonal skills
+ Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $140,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges.
***Please note, this is a hybrid position 3 days onsite/2 days remote***
**Purpose:**
This role is responsible for trial level clinical data strategy including database structure, content and meaning, acquisition, storage, retrieval, interchange, delivery and representation. This requires an in depth understanding of data collection, data flow management, data quality, data technology, dataset delivery, archiving and data standards. This role will collaborate with key study partners to define, implement, and deliver clinical data management packages. This role is responsible for providing trial leadership and ownership for a particular trial, set of trials, or programs.
**Primary Responsibilities:**
**Portfolio Strategy, Planning and Delivery**
+ Define Lilly business requirements for the study/program for vendors to deliver
+ Ensure that data management timeline and results are delivered to scope, cost, and time objectives
+ Perform project monitoring and quality oversight of sourcing providers for end-to-end data management activities - from study set up through trial execution through dataset delivery
+ Ensure vendor performance for the program-level flow of data, including across niche vendors and niche data sources (pharmacokinetic, immunogenicity, biomarker)
+ Drives data flow design through consultation, review, and approval of vendor work. Ensures the data flow design is aligned with the project hypothesis
+ Approve key outputs and results (i.e. Data Quality Delivery Plan, Data lock Plan, Project Plan, database, and observed datasets)
+ Define and approve data quality and submission outputs and results
**Project Management**
+ Ensure that data acquisition, database design, and observed dataset requirements are reflective of specific protocol objectives
+ Specifies the data collection tools and technology platforms for the trial/program
+ Drive standards decisions, implementation and compliance for the study/program
+ Help create scope scenarios and negotiate outcomes with study teams while taking into account the cost and value of scenarios
+ Facilitate/assimilate integration of disparate data sources into datasets for decision making
+ Use therapeutic knowledge and possess a deep understanding of the technology used to review data to ensure database deliverables are consistent and accurate
+ Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to data deliverables
**Communication**
+ Act as primary communication point for all data management activities related to a clinical study.
+ Report out status of data management milestones and data quality.
+ Partner with external data vendors: understand specifications to import multiple types of data, work with technical groups to ensure timely loads of external data sets into the sponsor's database.
+ Demonstrate excellent written and verbal communication skills, including the ability to represent the Data and Analytics organization and influence stakeholders to drive data-driven decisions.
+ Partner with cross-functional team members to ensure trial success through robust oversight/review.
**Process Improvement**
+ Continually seek and implement means of improving processes to reduce cycle time and decrease work effort
+ Represent data sciences' processes in multi-functional initiatives.
+ Actively engage in shared learning across the Data and Analytics organization.
+ Work with partners to increase vendor/partner efficiencies
**Minimum Qualification Requirements:**
+ Master's degree in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, Computer Sciences (or Bachelor's degree plus 3 or more years of experience in clinical data management or areas that closely intersect with clinical data management e.g., statistics, data analytics, information technology, health outcomes, etc.)
**Other** **Information/Additional** **Preferences:**
+ Demonstrated ability to set and implement plans to improve complex clinical data management processes and capabilities
+ Demonstrated ability to effectively partner/influence a remote team and drive a technical project to deliver results
+ Experience with application of clinical data management skills such as data flow, data quality & integrity, data interchange, data mining, and data representation principles
+ Demonstrated ability to lead development of creative data solutions to address clinical development challenges
+ Passionate about improving technological solutions using new technologies
+ Society of Clinical Data Management certification
+ Working knowledge of programming languages & Industry tools such as Tableau, PowerBI, Python, SAS, 'R' and Shiny for reporting, metrics and visualizations along with P-SQL, T-SQL for DBMS.
+ Experience with the following:
+ Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions
+ Utilization of clinical/drug development knowledge and an ability to collaborate closely effectively with study team members (i.e. Statistics, PK, Operations, Medical)
+ Strong therapeutic/scientific knowledge in the field of research
+ Knowledge of medical terminology
+ Domestic and International travel may be required
+ Ability to balance multiple activities, prioritize and manage ambiguity
+ Demonstrated exemplary teamwork/interpersonal skills
+ Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $140,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
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2
Clinical Research Manager Clinical Trials
80017 Aurora, Colorado
University of Colorado
Posted 1 day ago
Job Viewed
Job Description
**Clinical Research Manager Clinical Trials**
**Description**
**University of Colorado Anschutz Medical Campus**
**Department: Ophthalmology**
**Job Title: Clinical Research Manager - Clinical Trials**
**Position # - Requisition #37841**
**Job Summary:**
**Key Responsibilities:**
+ Maintains clinical trial finance records to ensure timely billing and payment by sponsors.
**Work Location:**
Onsite
**Why Join Us:**
**Why work for the University?**
+ Medical: Multiple plan options
+ Dental: Multiple plan options
+ Additional Insurance: Disability, Life, Vision
+ Retirement 401(a) Plan: Employer contributes 10% of your gross pay
+ Paid Time Off: Accruals over the year
+ Vacation Days: 22/year (maximum accrual 352 hours)
+ Sick Days: 15/year (unlimited maximum accrual)
+ Holiday Days: 10/year
+ Tuition Benefit: Employees have access to this benefit on all CU campuses
+ ECO Pass: Reduced rate RTD Bus and light rail service
**Qualifications:**
**Minimum Qualifications:**
+ Bachelor's degree in any field
+ **Substitution** : A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year-for-year basis.
+ AND Five (5) years of clinical research or related experience
**Preferred Qualifications:**
+ Bachelor's degree in science or a related field
+ Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
+ Three or more years of clinical research experience in an ophthalmic practice setting.
+ Certification as a Certified Ophthalmic Technician (COT) or higher with a minimum of 2 years of relevant ophthalmic medical experience may be substituted for degree
+ Classroom and medical experience in ophthalmology to include refraction, tonometry, ETDRS vision testing, pupillary assessment, and ability to perform basic slit lamp exam is required.
+ Current Clinical Research Certification (CCRC, CCRA, CCRP) or meets criteria to sit for exam within one year.
+ Non-clinical OD or MD with clinical research experience
**Knowledge, Skills and Abilities:**
+ Ability to set goals, motivate team members to achieve results
+ Knowledge of supervisory techniques, management principles, and organizational leadership
+ Expert knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
+ Ability to communicate effectively, both in writing and orally
+ Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
+ Outstanding customer service skills
+ Knowledge of basic human anatomy, physiology, medical terminology
**How to Apply:**
**Screening of Applications Begins:**
**Anticipated Pay Range:**
+ $71,244 - $90,622
**Equal Employment Opportunity Statement:**
**ADA Statement:**
**Background Check Statement:**
**Vaccination Statement:**
**Job Category**
**Primary Location**
**Schedule**
**Posting Date**
**Unposting Date**
**To apply, visit ( 2025 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency ( Research Manager - Clinical Trials - 37841 University Staff
+ Provide oversight, direction and leadership for all clinical research operations within unit
+ Hire, train, supervise, coach and direct team members
+ Monitor and actively direct workload within unit
+ Provide oversight of Good Clinical Practice (GCP) in all studies
+ Develop program/project goals and communicate goals and outcomes with a variety of stakeholders
+ Participate in tactical and strategic program/project development and planning
+ Participate in program/project budget development processes, including grant writing and submission processes, and regularly reviews to ensure alignment
+ Lead and participate in program/project start up and close out functions
- this role is expected to work onsite and is located in Aurora, Colorado.
The Department of Ophthalmology is housed in the Sue Anschutz-Rodgers Eye Center on the Anschutz Medical Campus. This state-of-the-art facility is one of the largest eye centers in the country and serves not only patients in the Rocky Mountain region but also patients all over the world.The technological innovations conceived and developed by departmental faculty have changed the practice of eye care throughout the world. Our educational programs train the next generation of leaders in ophthalmology. Our specialists have developed national and international reputations for excellence in routine and complex ophthalmic care. We have invested heavily in tracking our clinical outcomes and we are proud that our clinicians perform at the highest levels in their respective fields.The mission of the Department of Ophthalmology is to be a nationally recognized department of ophthalmology by providing exemplary patient care founded on educational leadership, innovative research, and high ethical standards.We have AMAZING benefits and offerexceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:There are many additional perks & programs with the CU Advantage ( .
Applicants must meet minimum qualifications at the time of hire.
For full consideration, please submit the following document(s):1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position2. Curriculum vitae / Resume3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email addressQuestions should be directed to: Ashley Woodhouse ( and continues until position is filled. For best consideration, apply by October 1, 2025.
The starting salary range for this position has been established atThe above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.Total Compensation Calculator ( is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at ( .
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases ( . If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program ( . Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 20254 - SOM-OP GENERAL OPERATIONS : Full-time : Sep 24, 2025 : Ongoing Posting Contact Name: Ashley Woodhouse Posting Contact Email: ( Position Number: jeid-917c8d2260e5b240bb40b662b8565ac6
The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.
**Description**
**University of Colorado Anschutz Medical Campus**
**Department: Ophthalmology**
**Job Title: Clinical Research Manager - Clinical Trials**
**Position # - Requisition #37841**
**Job Summary:**
**Key Responsibilities:**
+ Maintains clinical trial finance records to ensure timely billing and payment by sponsors.
**Work Location:**
Onsite
**Why Join Us:**
**Why work for the University?**
+ Medical: Multiple plan options
+ Dental: Multiple plan options
+ Additional Insurance: Disability, Life, Vision
+ Retirement 401(a) Plan: Employer contributes 10% of your gross pay
+ Paid Time Off: Accruals over the year
+ Vacation Days: 22/year (maximum accrual 352 hours)
+ Sick Days: 15/year (unlimited maximum accrual)
+ Holiday Days: 10/year
+ Tuition Benefit: Employees have access to this benefit on all CU campuses
+ ECO Pass: Reduced rate RTD Bus and light rail service
**Qualifications:**
**Minimum Qualifications:**
+ Bachelor's degree in any field
+ **Substitution** : A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year-for-year basis.
+ AND Five (5) years of clinical research or related experience
**Preferred Qualifications:**
+ Bachelor's degree in science or a related field
+ Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
+ Three or more years of clinical research experience in an ophthalmic practice setting.
+ Certification as a Certified Ophthalmic Technician (COT) or higher with a minimum of 2 years of relevant ophthalmic medical experience may be substituted for degree
+ Classroom and medical experience in ophthalmology to include refraction, tonometry, ETDRS vision testing, pupillary assessment, and ability to perform basic slit lamp exam is required.
+ Current Clinical Research Certification (CCRC, CCRA, CCRP) or meets criteria to sit for exam within one year.
+ Non-clinical OD or MD with clinical research experience
**Knowledge, Skills and Abilities:**
+ Ability to set goals, motivate team members to achieve results
+ Knowledge of supervisory techniques, management principles, and organizational leadership
+ Expert knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
+ Ability to communicate effectively, both in writing and orally
+ Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
+ Outstanding customer service skills
+ Knowledge of basic human anatomy, physiology, medical terminology
**How to Apply:**
**Screening of Applications Begins:**
**Anticipated Pay Range:**
+ $71,244 - $90,622
**Equal Employment Opportunity Statement:**
**ADA Statement:**
**Background Check Statement:**
**Vaccination Statement:**
**Job Category**
**Primary Location**
**Schedule**
**Posting Date**
**Unposting Date**
**To apply, visit ( 2025 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency ( Research Manager - Clinical Trials - 37841 University Staff
+ Provide oversight, direction and leadership for all clinical research operations within unit
+ Hire, train, supervise, coach and direct team members
+ Monitor and actively direct workload within unit
+ Provide oversight of Good Clinical Practice (GCP) in all studies
+ Develop program/project goals and communicate goals and outcomes with a variety of stakeholders
+ Participate in tactical and strategic program/project development and planning
+ Participate in program/project budget development processes, including grant writing and submission processes, and regularly reviews to ensure alignment
+ Lead and participate in program/project start up and close out functions
- this role is expected to work onsite and is located in Aurora, Colorado.
The Department of Ophthalmology is housed in the Sue Anschutz-Rodgers Eye Center on the Anschutz Medical Campus. This state-of-the-art facility is one of the largest eye centers in the country and serves not only patients in the Rocky Mountain region but also patients all over the world.The technological innovations conceived and developed by departmental faculty have changed the practice of eye care throughout the world. Our educational programs train the next generation of leaders in ophthalmology. Our specialists have developed national and international reputations for excellence in routine and complex ophthalmic care. We have invested heavily in tracking our clinical outcomes and we are proud that our clinicians perform at the highest levels in their respective fields.The mission of the Department of Ophthalmology is to be a nationally recognized department of ophthalmology by providing exemplary patient care founded on educational leadership, innovative research, and high ethical standards.We have AMAZING benefits and offerexceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:There are many additional perks & programs with the CU Advantage ( .
Applicants must meet minimum qualifications at the time of hire.
For full consideration, please submit the following document(s):1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position2. Curriculum vitae / Resume3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email addressQuestions should be directed to: Ashley Woodhouse ( and continues until position is filled. For best consideration, apply by October 1, 2025.
The starting salary range for this position has been established atThe above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.Total Compensation Calculator ( is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at ( .
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases ( . If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program ( . Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 20254 - SOM-OP GENERAL OPERATIONS : Full-time : Sep 24, 2025 : Ongoing Posting Contact Name: Ashley Woodhouse Posting Contact Email: ( Position Number: jeid-917c8d2260e5b240bb40b662b8565ac6
The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.
View Now
3
Manager, Clinical Trials Registry
02446
Dana-Farber Cancer Institute
Posted today
Job Viewed
Job Description
**This position's work location is remote with occasional time onsite as needed. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).**
The Manager, Clinical Trials Registry is responsible for overseeing the management, compliance, and operational efficiency of Dana-Farber/Havard Cancer Center's clinical trials registry. Reporting to the Director, Office of Data Quality, in the department of Clinical Research Management, this role ensures all clinical trials are accurately registered, updated, and reported in compliance with federal regulations, institutional policies, and sponsor requirements. The Manager collaborates with investigators, research teams, and regulatory staff to maintain the integrity of clinical trial data and ensure timely submissions to registries such as ClinicalTrials.gov. This position plays a critical role in supporting the Institute's commitment to transparency, research excellence, and regulatory compliance.
The primary purpose of the Office of Data Quality (ODQ) is to develop, maintain, implement and continuously improve a program that supports the highest standards of data quality in clinical research.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
+ Oversee the registration, maintenance, and reporting of clinical trials in compliance with federal regulations, including FDAAA 801, NIH policies, and other applicable guidelines.
+ Assist investigators and study teams with accurate submissions to ClinicalTrials.gov and other applicable registries, including initial registrations, updates, and results reporting.
+ Collaborate with investigators, study teams, and regulatory staff to resolve issues related to trial registration and reporting.
+ Conduct regular audits of registry data to ensure accuracy, completeness, and compliance with applicable standards.
+ Provide training and guidance to research staff on clinical trial registration requirements, submission processes, and best practices.
+ Represent the Office of Data Quality in institutional and external meetings related to clinical trial reporting.
+ Generate reports and metrics on clinical trial registration compliance for leadership and regulatory oversight committees.
+ Supervise staff, including hiring, training, and performance management.
+ Develop staff to achieve individual, team, departmental, and organizational goals by setting clear expectations and providing regular feedback.
+ Ensure compliance with policies, monitor work quality, and support career growth through mentoring and training.
+ Collaborate with senior management and HR to address performance issues and foster an inclusive and productive work environment.
**SUPERVISORY RESPONSIBILITIES:**
+ Directly supervises at least two staff. Hires, develops, and manages staff to achieve organizational goals. Sets clear expectations, delivers feedback, and monitors performance for quality, efficiency, and compliance with policies and procedures. Mentors staff, fosters career growth, and cultivates a positive and productive work environment.
+ Bachelor's degree required
+ Minimum of 5 years of experience in clinical research, regulatory compliance, or clinical trial operations, with at least 2 years in a supervisory or management role.
+ Certification in clinical research (e.g., CCRP, CCRC, or CCRA) preferred.
**KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:**
+ Comprehensive knowledge of clinical trial regulations, including FDAAA 801, ICMJE requirements, and NIH policies.
+ Familiarity with ClinicalTrials.gov and other clinical trial registries, including their submission processes and requirements.
+ Strong organizational and project management skills, with the ability to manage multiple priorities and deadlines.
+ Excellent written and verbal communication skills, with the ability to convey complex regulatory requirements to diverse audiences.
+ Proficiency in data management systems and tools, including Microsoft Office Suite and clinical trial management systems (CTMS).
+ Strong analytical and problem-solving skills, with attention to detail and accuracy.
+ Ability to work collaboratively with cross-functional teams and build effective relationships with stakeholders.
+ Leadership and supervisory skills, including the ability to mentor and develop staff.
**Pay Transparency Statement**
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications.
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA)
$126,800 - $139,800
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
**EEOC Poster**
The Manager, Clinical Trials Registry is responsible for overseeing the management, compliance, and operational efficiency of Dana-Farber/Havard Cancer Center's clinical trials registry. Reporting to the Director, Office of Data Quality, in the department of Clinical Research Management, this role ensures all clinical trials are accurately registered, updated, and reported in compliance with federal regulations, institutional policies, and sponsor requirements. The Manager collaborates with investigators, research teams, and regulatory staff to maintain the integrity of clinical trial data and ensure timely submissions to registries such as ClinicalTrials.gov. This position plays a critical role in supporting the Institute's commitment to transparency, research excellence, and regulatory compliance.
The primary purpose of the Office of Data Quality (ODQ) is to develop, maintain, implement and continuously improve a program that supports the highest standards of data quality in clinical research.
Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
+ Oversee the registration, maintenance, and reporting of clinical trials in compliance with federal regulations, including FDAAA 801, NIH policies, and other applicable guidelines.
+ Assist investigators and study teams with accurate submissions to ClinicalTrials.gov and other applicable registries, including initial registrations, updates, and results reporting.
+ Collaborate with investigators, study teams, and regulatory staff to resolve issues related to trial registration and reporting.
+ Conduct regular audits of registry data to ensure accuracy, completeness, and compliance with applicable standards.
+ Provide training and guidance to research staff on clinical trial registration requirements, submission processes, and best practices.
+ Represent the Office of Data Quality in institutional and external meetings related to clinical trial reporting.
+ Generate reports and metrics on clinical trial registration compliance for leadership and regulatory oversight committees.
+ Supervise staff, including hiring, training, and performance management.
+ Develop staff to achieve individual, team, departmental, and organizational goals by setting clear expectations and providing regular feedback.
+ Ensure compliance with policies, monitor work quality, and support career growth through mentoring and training.
+ Collaborate with senior management and HR to address performance issues and foster an inclusive and productive work environment.
**SUPERVISORY RESPONSIBILITIES:**
+ Directly supervises at least two staff. Hires, develops, and manages staff to achieve organizational goals. Sets clear expectations, delivers feedback, and monitors performance for quality, efficiency, and compliance with policies and procedures. Mentors staff, fosters career growth, and cultivates a positive and productive work environment.
+ Bachelor's degree required
+ Minimum of 5 years of experience in clinical research, regulatory compliance, or clinical trial operations, with at least 2 years in a supervisory or management role.
+ Certification in clinical research (e.g., CCRP, CCRC, or CCRA) preferred.
**KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:**
+ Comprehensive knowledge of clinical trial regulations, including FDAAA 801, ICMJE requirements, and NIH policies.
+ Familiarity with ClinicalTrials.gov and other clinical trial registries, including their submission processes and requirements.
+ Strong organizational and project management skills, with the ability to manage multiple priorities and deadlines.
+ Excellent written and verbal communication skills, with the ability to convey complex regulatory requirements to diverse audiences.
+ Proficiency in data management systems and tools, including Microsoft Office Suite and clinical trial management systems (CTMS).
+ Strong analytical and problem-solving skills, with attention to detail and accuracy.
+ Ability to work collaboratively with cross-functional teams and build effective relationships with stakeholders.
+ Leadership and supervisory skills, including the ability to mentor and develop staff.
**Pay Transparency Statement**
The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate's relevant experience, skills and qualifications.
For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA)
$126,800 - $139,800
At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionate professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.
**EEOC Poster**
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4
Clinical Trials Coordinator - Urology
90006 Los Angeles, California
UCLA Health
Posted 2 days ago
Job Viewed
Job Description
Description
The Department of Urology is seeking to hire a full time Clinical Trials Coordinator. Under the direct supervision of the Clinical Trials Administrator, the Clinical Research Coordinator contributes to the overall operational management of clinical research / trial / study activities from design, set up, conduct, through closeout.
The ideal candidate is an experienced professional who has direct responsibility for the implementation of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities. You will recognize and perform necessary tasks to manage projects and prioritizes work to meet necessary deadlines. You will be responsible for planning and organizing necessary tasks to ensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). You will also collaborate with the Principal Investigator (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities as needed to support the administration of all aspects of studies, including, but not limited to, compliant conduct, financial management, and adequate personnel support.
Salary offers are determined based on various factors including, but not limited to, qualifications, experience, and equity.
Pay Range for this role is $33.63 - $54.11 hourly.
Qualifications
+ Bachelors Degree or 1-3 years of previous study coordination or clinical research coordination experience
+ Strong verbal and written communication skills along with strong interpersonal skills to effectively establish rapport, and build collaborate relationships.
+ Strong organizational capabilities to organize multiple projects and competing deadlines for efficiency and cost-effectiveness.
+ Analytical skills sufficient to work and solve address problems and identify solutions with reasoned judgment.
+ Ability to adapt to changing job demands and priorities; work flexible hours to accommodate research deadlines.
+ Ability to respond to situations in an appropriate and professional manner.
+ Ability to concentrate and focus in a work environment that contains distracting stimuli and competing deadlines.
+ Ability to be flexible in handling work delegated by more than one individual.
+ Typing and computer skill/ability including word-processing, use of spreadsheets, email, data entry. Ability to navigate numerous software programs and applications.
+ Ability to handle confidential material information with judgement and discretion.
+ Working knowledge of the clinical research regulatory framework and institutional requirements.
+ Mathematical skills Sufficient to prepare clinical research budgets, knowledge of math ability and knowledge of clinical trials research budgeting process to assist with the preparation of clinical trial budgets.
+ Working knowledge of FDA Code of Federal Regulations (CFR) and ICH Good Clinical Practice (GC) for clinical research.
+ Be available to work in more than one environment, travel to meetings, off-site visits, conferences, etc.
UCLA Health welcomes all individuals, without regard to race, sex, sexual orientation, gender identity, religion, national origin or disabilities, and we proudly look to each person's unique achievements and experiences to further set us apart.
The Department of Urology is seeking to hire a full time Clinical Trials Coordinator. Under the direct supervision of the Clinical Trials Administrator, the Clinical Research Coordinator contributes to the overall operational management of clinical research / trial / study activities from design, set up, conduct, through closeout.
The ideal candidate is an experienced professional who has direct responsibility for the implementation of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities. You will recognize and perform necessary tasks to manage projects and prioritizes work to meet necessary deadlines. You will be responsible for planning and organizing necessary tasks to ensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). You will also collaborate with the Principal Investigator (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities as needed to support the administration of all aspects of studies, including, but not limited to, compliant conduct, financial management, and adequate personnel support.
Salary offers are determined based on various factors including, but not limited to, qualifications, experience, and equity.
Pay Range for this role is $33.63 - $54.11 hourly.
Qualifications
+ Bachelors Degree or 1-3 years of previous study coordination or clinical research coordination experience
+ Strong verbal and written communication skills along with strong interpersonal skills to effectively establish rapport, and build collaborate relationships.
+ Strong organizational capabilities to organize multiple projects and competing deadlines for efficiency and cost-effectiveness.
+ Analytical skills sufficient to work and solve address problems and identify solutions with reasoned judgment.
+ Ability to adapt to changing job demands and priorities; work flexible hours to accommodate research deadlines.
+ Ability to respond to situations in an appropriate and professional manner.
+ Ability to concentrate and focus in a work environment that contains distracting stimuli and competing deadlines.
+ Ability to be flexible in handling work delegated by more than one individual.
+ Typing and computer skill/ability including word-processing, use of spreadsheets, email, data entry. Ability to navigate numerous software programs and applications.
+ Ability to handle confidential material information with judgement and discretion.
+ Working knowledge of the clinical research regulatory framework and institutional requirements.
+ Mathematical skills Sufficient to prepare clinical research budgets, knowledge of math ability and knowledge of clinical trials research budgeting process to assist with the preparation of clinical trial budgets.
+ Working knowledge of FDA Code of Federal Regulations (CFR) and ICH Good Clinical Practice (GC) for clinical research.
+ Be available to work in more than one environment, travel to meetings, off-site visits, conferences, etc.
UCLA Health welcomes all individuals, without regard to race, sex, sexual orientation, gender identity, religion, national origin or disabilities, and we proudly look to each person's unique achievements and experiences to further set us apart.
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5
Medical Writer Clinical Trials
07602 Hackensack, New Jersey
Hackensack Meridian Health
Posted today
Job Viewed
Job Description
Our team members are the heart of what makes us better.
At **Hackensack Meridian** **_Health_** we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community.
Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.
The **Medical Writer Clinical Trials** is responsible for analyzing, writing and editing technical documentation summarizing clinical study ideas into protocols and resulting publications as well as writing summarizing other scientific matters. This role will contribute to developing and implementing comprehensive workflows and project planning to ensure ongoing clinical trial compliance across the Disease Specific Oncology Research Programs. This includes, but is not limited to, overseeing and driving the clinical research trials development and analysis process to final deliverables in a timely and effective manner. This role will collaborate and communicate with teams of investigators and research staff to ensure continual process development and improvement, always emphasizing clarity in training and implementation with the highest standards of integrity.
**Education, Knowledge, Skills and Abilities Required** :
+ Bachelor's degree in a scientific or medical discipline.
+ Minimum of 5 or more years of experience in clinical healthcare environment.
+ Solid knowledge of Good Clinical Practice guidelines and Protection of Human Subjects regulations.
+ Strong attention to detail and customer service focus is required.
+ Excellent medical writing, communication, organizational, presentation, documentation, and interpersonal skills.
+ Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
+ Review and comply with all relevant HMH and Business Unit policies and procedures, and local, state, and Federal laws and regulations.
+ Mandatory education on human subject research and GCP (CITI Training and Certification).
+ Possesses beginning to working knowledge of subject matter.
+ Excellent written and verbal communication skills.
+ Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.
**Education, Knowledge, Skills and Abilities Preferred** :
+ Higher Education Degree (M.S., PhD, MD).
+ Knowledge of clinical trials and the regulation (local, state, and federal) of such.
+ Familiarity with basic scientific and healthcare principles and terminology.
If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!
Minimum rate of $63.05 Hourly
HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to:
+ Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness.
+ Experience: Years of relevant work experience.
+ Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training.
+ Skills: Demonstrated proficiency in relevant skills and competencies.
+ Geographic Location: Cost of living and market rates for the specific location.
+ Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization.
+ Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered.
Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts.
In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.
HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER
All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.
At **Hackensack Meridian** **_Health_** we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community.
Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.
The **Medical Writer Clinical Trials** is responsible for analyzing, writing and editing technical documentation summarizing clinical study ideas into protocols and resulting publications as well as writing summarizing other scientific matters. This role will contribute to developing and implementing comprehensive workflows and project planning to ensure ongoing clinical trial compliance across the Disease Specific Oncology Research Programs. This includes, but is not limited to, overseeing and driving the clinical research trials development and analysis process to final deliverables in a timely and effective manner. This role will collaborate and communicate with teams of investigators and research staff to ensure continual process development and improvement, always emphasizing clarity in training and implementation with the highest standards of integrity.
**Education, Knowledge, Skills and Abilities Required** :
+ Bachelor's degree in a scientific or medical discipline.
+ Minimum of 5 or more years of experience in clinical healthcare environment.
+ Solid knowledge of Good Clinical Practice guidelines and Protection of Human Subjects regulations.
+ Strong attention to detail and customer service focus is required.
+ Excellent medical writing, communication, organizational, presentation, documentation, and interpersonal skills.
+ Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
+ Review and comply with all relevant HMH and Business Unit policies and procedures, and local, state, and Federal laws and regulations.
+ Mandatory education on human subject research and GCP (CITI Training and Certification).
+ Possesses beginning to working knowledge of subject matter.
+ Excellent written and verbal communication skills.
+ Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.
**Education, Knowledge, Skills and Abilities Preferred** :
+ Higher Education Degree (M.S., PhD, MD).
+ Knowledge of clinical trials and the regulation (local, state, and federal) of such.
+ Familiarity with basic scientific and healthcare principles and terminology.
If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!
Minimum rate of $63.05 Hourly
HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to:
+ Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness.
+ Experience: Years of relevant work experience.
+ Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training.
+ Skills: Demonstrated proficiency in relevant skills and competencies.
+ Geographic Location: Cost of living and market rates for the specific location.
+ Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization.
+ Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered.
Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts.
In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.
HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER
All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.
View Now
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6
Financial Assistant - Clinical Trials
27599 Cary, North Carolina
UNC Health Care
Posted 1 day ago
Job Viewed
Job Description
**Description**
Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve.
Summary:
Performs a variety of accounting and other financial processing support duties including the processing of accounting forms and documents, compiling, formatting and typing financial reports and monitoring and reconciling accounts. Positions report to departmental supervisors and managers.
Responsibilities:
1. Answers and directs telephone calls and visitors
2. Compiles, formats and types a variety of financial reports using office support software packages. May research and gather data from several sources. May analyze data and make recommendations to supervisor.
3. May oversee the work of less experienced staff.
4. Monitors and reconciles financial accounts and prepares account and statement re-conciliations. Provides account status to supervisor
5. Performs general office duties such as opening, routing and disseminating mail and maintaining filing systems
6. Prepares and processes accounting forms and documents. Reviews such documents for accuracy and completeness
**Other Information**
**Education Requirements:**
● High School diploma or GED
**Licensure/Certification Requirements:**
● No licensure or certification required.
**Professional Experience Requirements:**
● Two (2) years of office assistant/secretarial experience or an equivalent combination of education, training and experience
**Knowledge/Skills/and Abilities Requirements:**
**Job Details**
Legal Employer: STATE
Entity: UNC Faculty Physicians
Organization Unit: Clinical trials Unit Passthrough
Work Type: Full Time
Standard Hours Per Week: 40.00
Salary Range: $19.59 - $27.84 per hour (Hiring Range)
Pay offers are determined by experience and internal equity
Work Assignment Type: Hybrid
Work Schedule: Day Job
Location of Job: US:NC:Chapel Hill
Exempt From Overtime: Exempt: No
This is a State position employed by UNC Health Care System with UNC Health benefits. If, however, you are presently an employee of another North Carolina agency and currently participate in TSERS or the ORP, you will be eligible to continue participating in those plans at UNC Health.
Qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, status as a protected veteran or political affiliation.
UNC Health makes reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as applicants and employees with disabilities. All interested applicants are invited to apply for career opportunities. Please email if you need a reasonable accommodation to search and/or to apply for a career opportunity.
Qualified applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve.
Summary:
Performs a variety of accounting and other financial processing support duties including the processing of accounting forms and documents, compiling, formatting and typing financial reports and monitoring and reconciling accounts. Positions report to departmental supervisors and managers.
Responsibilities:
1. Answers and directs telephone calls and visitors
2. Compiles, formats and types a variety of financial reports using office support software packages. May research and gather data from several sources. May analyze data and make recommendations to supervisor.
3. May oversee the work of less experienced staff.
4. Monitors and reconciles financial accounts and prepares account and statement re-conciliations. Provides account status to supervisor
5. Performs general office duties such as opening, routing and disseminating mail and maintaining filing systems
6. Prepares and processes accounting forms and documents. Reviews such documents for accuracy and completeness
**Other Information**
**Education Requirements:**
● High School diploma or GED
**Licensure/Certification Requirements:**
● No licensure or certification required.
**Professional Experience Requirements:**
● Two (2) years of office assistant/secretarial experience or an equivalent combination of education, training and experience
**Knowledge/Skills/and Abilities Requirements:**
**Job Details**
Legal Employer: STATE
Entity: UNC Faculty Physicians
Organization Unit: Clinical trials Unit Passthrough
Work Type: Full Time
Standard Hours Per Week: 40.00
Salary Range: $19.59 - $27.84 per hour (Hiring Range)
Pay offers are determined by experience and internal equity
Work Assignment Type: Hybrid
Work Schedule: Day Job
Location of Job: US:NC:Chapel Hill
Exempt From Overtime: Exempt: No
This is a State position employed by UNC Health Care System with UNC Health benefits. If, however, you are presently an employee of another North Carolina agency and currently participate in TSERS or the ORP, you will be eligible to continue participating in those plans at UNC Health.
Qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, status as a protected veteran or political affiliation.
UNC Health makes reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as applicants and employees with disabilities. All interested applicants are invited to apply for career opportunities. Please email if you need a reasonable accommodation to search and/or to apply for a career opportunity.
Qualified applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
View Now
7
Clinical Trials Nurse - Lymphoma
10176 New York, New York
Memorial Sloan-Kettering Cancer Center
Posted 2 days ago
Job Viewed
Job Description
**About Us:**
The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe.
**Clinical Trials Nurse - Lymphoma**
**Exciting Opportunity at MSK:** We're looking for a Clinical Trials Nurse in Lymphoma to join our team! In this role, you'll play a vital part in delivering comprehensive patient care, applying your expertise to assess, plan, implement, and evaluate treatments in both inpatient and outpatient settings.
**Role Overview:**
+ Provide as an integral member of the clinical research team deliver direct nursing care to research study Hematology participants.
+ Implement the standards for research protocols in compliance with regulatory, institutional and external agencies.
+ Work within a Nurse-Physician based Ambulatory Care Practice Model.
+ Perform patient assessment, offer patient education and patient/family support
+ Act as part of a multidisciplinary team to provide continuity of care to patients throughout various stages of treatment on protocol and follow-up.
+ Participate in an **individualized training/orientation program** geared to teaching or reinforcing the principles of Clinical Trials Nursing practiced at MSKCC
**Key Qualifications:**
+ New York State RN license
+ Bachelor of Science degree in Nursing
+ Three years Clinical Nursing experience, within either an Oncology or Hemalignancy Environment
+ Preferably Lymphoma
+ Clinical research nursing experience preferred but not vital
+ Proficiency with clinical and office software (Microsoft Word, Outlook, Excel)
+ BCLS
**Core Skills:**
+ Productive and eager to embrace new opportunities and tough challenges with a sense of urgency, high energy, and passion.
+ A good decision-maker, with proven success at making timely decisions that maintain high standards of nursing care within the organization.
+ Actively seeking new ways to grow and be challenged, using both formal and informal development channels.
+ Approachable and comfortable with diverse groups of people and able to make others comfortable with you.
+ An effective communicator, capable of determining how best to reach different audiences and driving communications based on that understanding.
+ Capable of building strong customer relationships and delivering customer-centric solutions.
**Additional Information:**
+ **Hours:** 4, 10 hour days shifts flexed Monday - Friday, no weekends no holidays
+ **Location:** David H. Koch
Pay Range: $110,700.00 - $177,100.00
FSLA Status: Exempt
**Closing** :
At MSK, we believe in fair, competitive pay that reflects your job, experience, and skills.
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe.
**Clinical Trials Nurse - Lymphoma**
**Exciting Opportunity at MSK:** We're looking for a Clinical Trials Nurse in Lymphoma to join our team! In this role, you'll play a vital part in delivering comprehensive patient care, applying your expertise to assess, plan, implement, and evaluate treatments in both inpatient and outpatient settings.
**Role Overview:**
+ Provide as an integral member of the clinical research team deliver direct nursing care to research study Hematology participants.
+ Implement the standards for research protocols in compliance with regulatory, institutional and external agencies.
+ Work within a Nurse-Physician based Ambulatory Care Practice Model.
+ Perform patient assessment, offer patient education and patient/family support
+ Act as part of a multidisciplinary team to provide continuity of care to patients throughout various stages of treatment on protocol and follow-up.
+ Participate in an **individualized training/orientation program** geared to teaching or reinforcing the principles of Clinical Trials Nursing practiced at MSKCC
**Key Qualifications:**
+ New York State RN license
+ Bachelor of Science degree in Nursing
+ Three years Clinical Nursing experience, within either an Oncology or Hemalignancy Environment
+ Preferably Lymphoma
+ Clinical research nursing experience preferred but not vital
+ Proficiency with clinical and office software (Microsoft Word, Outlook, Excel)
+ BCLS
**Core Skills:**
+ Productive and eager to embrace new opportunities and tough challenges with a sense of urgency, high energy, and passion.
+ A good decision-maker, with proven success at making timely decisions that maintain high standards of nursing care within the organization.
+ Actively seeking new ways to grow and be challenged, using both formal and informal development channels.
+ Approachable and comfortable with diverse groups of people and able to make others comfortable with you.
+ An effective communicator, capable of determining how best to reach different audiences and driving communications based on that understanding.
+ Capable of building strong customer relationships and delivering customer-centric solutions.
**Additional Information:**
+ **Hours:** 4, 10 hour days shifts flexed Monday - Friday, no weekends no holidays
+ **Location:** David H. Koch
Pay Range: $110,700.00 - $177,100.00
FSLA Status: Exempt
**Closing** :
At MSK, we believe in fair, competitive pay that reflects your job, experience, and skills.
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
View Now
8
Manager, Biostatistics - Clinical Trials
55401 Minneapolis, Minnesota
Be The Match
Posted today
Job Viewed
Job Description
Job Description
Strategic planning:
REQUIRED QUALIFICATIONS:
Strategic planning:
REQUIRED QUALIFICATIONS:
POSITION SUMMARY:
The Center for International Blood and Marrow Transplant Research (CIBMTR) and the Clinical Research Organization (CRO) Services team provides a unique resource of data and statistical expertise to the scientific community for addressing important issues in hematopoietic cell transplantation and cellular therapies space. This role ensures the highest quality of statistical and programming support of our hematopoietic stem cell and cellular therapy clinical trials that further the mission, vision and strategic plan of NMDP. The Manager, Biostatistics role will ensure the statistical aspects of clinical activities meet required standards and are robust and valid. This role directly oversees biostatisticians and statistical programmers including hiring, training, leading, overseeing, reviewing work and coaching for growth and development.
ACCOUNTABILITIES:
Trials oversight:
- Complete statistical design, planning and analysis duties of individual studies, as needed.
- Coordinate and oversee statistical deliverables and programming activities of CRO services clinical trials.
- Collaborate with study statisticians to provide expertise in design of clinical trials.
- Review and approve protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Figure (TLF) shells, datafile specifications, clinical study reports, protocol deviations, clinical publications, and other study documents or communications.
- Provide guidance on implementation of statistical analysis plans to the study biostatisticians.
- Develop and maintain statistical and programming policies, guidelines, and procedures (SOPs, training manuals, etc.).
- Develop and maintain a program to train biostatistician and statistical programmer team members, based on current needs of CRO Services portfolio and strategic direction.
- Lead standardization efforts, process improvements, and best practices for the team and contribute to cross-functional process improvement efforts.
Strategic planning:
- Define team goals and strategy on an ongoing basis, in collaboration with the Senior Manager, Biostatistics.
- Provide innovation ideas to Senior Manager, Biostatistics on improving current processes and deliverables including methodology, best practices, and process improvements to maximize biostatistics value and increase efficiency in current resources.
Functional leadership:
- Stay up to date on the latest developments in the statistics and/or programming fields and contribute to scientific advances in the field. Educate the team on new developments and look for ways to implement into current workstreams.
- Plan, manage, and track team activities, timelines, and resources.
- Responsible for hiring, development and performance management of assigned team members; ensure team alignment with other department functions.
- Resolve standard and complex issues raised by the team; escalate unprecedented issues.
- Coach and develop the team to meet their objectives and growth goals.
- Facilitate collaboration and interaction between Biostatistics and other teams (Data Management, Safety, Project Management, Monitoring, PRO, Clinical, etc.).
- Cultivates a culture of inquiry, improvement, and equity. Encourages team members to promote the NMDP values through their daily work.
REQUIRED QUALIFICATIONS:
Knowledge of:
- Logistic regression, linear regression, survival analysis and other core statistical methods.
- Research study design principles and statistical standards for Phase I-III clinical trials.
- Scientific and therapeutic research concepts, experience in oncology a benefit.
- Advanced analytical techniques and statistical programming, with high-level proficiency in SAS (and optionally R).
- Regulatory guidance for clinical trials (e.g. ICH, FDA).
Ability to:
- Think critically.
- Lead and manage a team effectively.
- Influence colleagues and stakeholders regarding adoption of new ideas.
- Demonstrate strong oral and written communication; demonstrate public speaking effectiveness.
- Manage conflict.
- Advise senior leaders with confidence on relevant topics.
- Exhibit strong project management skills with a demonstrated ability to manage teams project milestones in a timely manner.
- Program with statistical analysis programs, e.g. SAS, R.
Education and/or Experience:
- Master's degree required. Biostatistics concentration preferred, or closely related field where statistical design and analyses comprised the primary course of study and application.
- 5+ years' experience in performing statistical design/analysis in clinical trials space.
- 2+ years experience in people leadership or equivalent experience mentoring and coaching others.
- Preference given to candidates with experience working in the pharmaceutical/medical device industry and working knowledge of CDISC standards.
POSITION SUMMARY:
The Center for International Blood and Marrow Transplant Research (CIBMTR) and the Clinical Research Organization (CRO) Services team provides a unique resource of data and statistical expertise to the scientific community for addressing important issues in hematopoietic cell transplantation and cellular therapies space. This role ensures the highest quality of statistical and programming support of our hematopoietic stem cell and cellular therapy clinical trials that further the mission, vision and strategic plan of NMDP. The Manager, Biostatistics role will ensure the statistical aspects of clinical activities meet required standards and are robust and valid. This role directly oversees biostatisticians and statistical programmers including hiring, training, leading, overseeing, reviewing work and coaching for growth and development.
ACCOUNTABILITIES:
Trials oversight:
- Complete statistical design, planning and analysis duties of individual studies, as needed.
- Coordinate and oversee statistical deliverables and programming activities of CRO services clinical trials.
- Collaborate with study statisticians to provide expertise in design of clinical trials.
- Review and approve protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Figure (TLF) shells, datafile specifications, clinical study reports, protocol deviations, clinical publications, and other study documents or communications.
- Provide guidance on implementation of statistical analysis plans to the study biostatisticians.
- Develop and maintain statistical and programming policies, guidelines, and procedures (SOPs, training manuals, etc.).
- Develop and maintain a program to train biostatistician and statistical programmer team members, based on current needs of CRO Services portfolio and strategic direction.
- Lead standardization efforts, process improvements, and best practices for the team and contribute to cross-functional process improvement efforts.
Strategic planning:
- Define team goals and strategy on an ongoing basis, in collaboration with the Senior Manager, Biostatistics.
- Provide innovation ideas to Senior Manager, Biostatistics on improving current processes and deliverables including methodology, best practices, and process improvements to maximize biostatistics value and increase efficiency in current resources.
Functional leadership:
- Stay up to date on the latest developments in the statistics and/or programming fields and contribute to scientific advances in the field. Educate the team on new developments and look for ways to implement into current workstreams.
- Plan, manage, and track team activities, timelines, and resources.
- Responsible for hiring, development and performance management of assigned team members; ensure team alignment with other department functions.
- Resolve standard and complex issues raised by the team; escalate unprecedented issues.
- Coach and develop the team to meet their objectives and growth goals.
- Facilitate collaboration and interaction between Biostatistics and other teams (Data Management, Safety, Project Management, Monitoring, PRO, Clinical, etc.).
- Cultivates a culture of inquiry, improvement, and equity. Encourages team members to promote the NMDP values through their daily work.
REQUIRED QUALIFICATIONS:
Knowledge of:
- Logistic regression, linear regression, survival analysis and other core statistical methods.
- Research study design principles and statistical standards for Phase I-III clinical trials.
- Scientific and therapeutic research concepts, experience in oncology a benefit.
- Advanced analytical techniques and statistical programming, with high-level proficiency in SAS (and optionally R).
- Regulatory guidance for clinical trials (e.g. ICH, FDA).
Ability to:
- Think critically.
- Lead and manage a team effectively.
- Influence colleagues and stakeholders regarding adoption of new ideas.
- Demonstrate strong oral and written communication; demonstrate public speaking effectiveness.
- Manage conflict.
- Advise senior leaders with confidence on relevant topics.
- Exhibit strong project management skills with a demonstrated ability to manage teams project milestones in a timely manner.
- Program with statistical analysis programs, e.g. SAS, R.
Education and/or Experience:
- Master's degree required. Biostatistics concentration preferred, or closely related field where statistical design and analyses comprised the primary course of study and application.
- 5+ years' experience in performing statistical design/analysis in clinical trials space.
- 2+ years experience in people leadership or equivalent experience mentoring and coaching others.
- Preference given to candidates with experience working in the pharmaceutical/medical device industry and working knowledge of CDISC standards.
Apply Now
9