2,516 Clinical Data Director jobs in the United States

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.
***This position requires living in the Indianapolis, IN area - working in a hybrid capacity which includes: 3 days onsite/2 days remote - a generous relocation package can be included with offer***
The **Associate Director- Submission Data Delivery** role leads all aspects of global consistency of medical data; structure, content and meaning, acquisition, storage, retrieval, interchange and representation. This requires an in-depth understanding of data collection, data flow management, data quality, data technology, data archiving, data standards, and submission process.
**Responsibilities:**
The Associate Director-Submission Data Delivery provides technical leadership and process ownership for Statistics, Data and Analytics.
▪ Apply broad process/technology knowledge to ensure clinical trials are consistent and accurate
▪ Act as the main contact within the Statistics, Data and Analytics organization for development and support of process and technology
▪ Communicates the global data strategy across the organization as it relates to process and technology. Influence to proactively resolve complex regulatory and business issues related to process and technology
▪ Oversight of submission data packages for SDTM, ADaM, PK/PD, and other data.
▪ This role will liaise with product and study teams, submission teams, Statistics, Data and Analytics, regulatory and vendors throughout the submission preparation process and post submission regulatory requests for data.
**Process/Technology Strategy Development and Management:**
▪ Accountable for defining, delivering, and improving global processes and/or technology to facilitate the reliable planning and execution of results.
▪ Proactively identify, monitor and communicate global customer needs/requirements related to process and/or technology performance and improvements as the need arises, across TA/Regions/Functions.
▪ Accountable for ensuring process and/or technology interfaces are optimized across Statistics, Data and Analytics.
**Process Improvement:**
▪ Continually seek and implement means of improving processes to reduce cycle time and decrease work effort to improve the return of the investment of the assets managed.
**Basic Requirements:**
▪ Bachelor's degree ideally in a scientific area
▪ Minimum 5 years of clinical trial data experience in drug development in areas intersecting (e.g. clinical operations, statistics, information technology, health outcomes, regulatory, etc.)
▪ Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
**Preferred Qualifications:**
+ In depth experience with SDTM, ADaM, PK/PD, and other data
+ Experience with R, Python and SAS
+ Strong technical experience and understanding of the data submission process in clinical data trials.
+ Experience with project management and leading without authority, while influencing submission teams and reporting to stakeholders
+ Understanding the regulatory guidelines and current expectations (FDA, PMDA, etc) along with experience with RIM
+ Pinnacle 21 experience, define .xml, OSI, and other submission data deliverables
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
$111,000 - $162,800
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 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

**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**

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.

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.

**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.

**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.

Job Description

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.

Responsibilities

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.

**All the benefits and perks you need for you and your family:**
+ Benefits from Day One
+ Paid Days Off from Day One
+ Career Development
+ Whole Person Wellbeing Resources
+ Mental Health Resources and Support
+ Debt-free Education* (Certifications and Degrees without out-of-pocket tuition expense)
**Our promise to you:**
Joining AdventHealth is about being part of something bigger. It's about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind, and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that **together** we are even better.
**Schedule:** Full Time
**Shift** : Days
**Location:** 601 EAST ROLLINS STREET, Orlando, 32803
**The role you'll contribute:**
The Clinical Research Data Operations Supervisor serves the AdventHealth Research Institute (AHRI) providing oversight of the conduct and data quality of industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, Food and Drug Administration (FDA) regulations and International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines. The Supervisor is able to function as a Clinical Research Data Coordinator as needed and serves to train, mentor and develop the Clinical Research Data Coordinators and Research Support Assistants staff in the conduct of clinical research within the AdventHealth research enterprise at the institute level and may extend across multiple U.S. Division locations. Works closely with AHRI Managers and Leaders to facilitate the initiation through completion of clinical research studies in assigned areas. Provides day-to-day supervision and ongoing performance reviews of clinical research staff at the department level. Actively participates in outstanding customer service and accepts responsibility for maintaining positive relationships that are equally respectful to all.
**The value you'll bring to the team:**
+ Performs a variety of supervisory duties including, but not limited to, ensuring that the work environment is safe, secure and healthy, leading the hiring process of applicant review and selection, team development through one-on-one discussions, and manages performance management of research team members (i.e., direct reports) including providing positive discipline, constructive feedback, and Talent Care discussions.
+ Collaborates with Clinical Research Supervisors by supervising day-to-day activity of the clinical research team within their assigned area, including oversight of team's workflow productivity and maintenance of personnel and staffing schedules as affected by research protocols at any given time.
+ Serves as an expert and resource for the research team when barriers arise during day-to-day operations.
+ Monitor and evaluate the quality of data operations within their assigned area including, but not limited to, regularly reviewing monitor follow up visit letters/sponsor reports, and provide oversight on what action items require follow up.
Qualifications
**The expertise and experiences you'll need to succeed:**
+ Bachelor's degree in Healthcare Administration, Research, or related field and at least 2 years of experience in clinical research or
+ Associate's degree in Healthcare Administration, Research, or related field and at least 3 years of experience in clinical research or related field.
This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances. The salary range reflects the anticipated base pay range for this position. Individual compensation is determined based on skills, experience and other relevant factors within this pay range. The minimums and maximums for each position may vary based on geographical location.
**Category:** Research
**Organization:** AdventHealth Orlando
**Schedule:** Full-time
**Shift:** 1 - Day
**Req ID:**
We are an equal opportunity employer and do not tolerate discrimination based on race, color, creed, religion, national origin, sex, marital status, age or disability/handicap with respect to recruitment, selection, placement, promotion, wages, benefits and other terms and conditions of employment.