3,486 Healthcare Project Management jobs in the United States

Posting Details

Posting Summary

Functional Position Title
CLINICAL TRIALS MANAGER

Position Number
00059103

Appointment Type
Regular

Location-City
New Orleans

School/Division
EXECUTIVE MANAGEMENT

Department
VCAA-Institutional Review Boar

Position Summary

The Clinical Trials Manager is responsible for the leadership and operational oversight of the Clinical Trials Office (CTO) at LSU Health Sciences Center. This role manages all aspects of clinical trial activation and administration, including contract and budget negotiation, regulatory approvals, compliance, and staff management. The Manager works closely with faculty investigators, sponsors, CROs, and institutional stakeholders to ensure the efficient, timely, and compliant execution of clinical trials across the institution. This position also plays a strategic role in continuous process improvement, policy development, and staff development.

Additional Position Information

Minimum Qualifications

Required Education
Bachelor's

If Other Required Education, please specify

Discipline(s)

Certifications/Licenses Required

Indicate the minimum number of years required to do the job
5

Indicate the type of experience required to do the job
Clinical Research Administration

Indicate if any combination of specific experience, training and education may be substituted for the required education or experience

Seven total years of equivalent experience in a related field such as healthcare administration, regulatory compliance, or research coordination may substitute for Clinical Research Administration experience.
Master's degree in biological science, healthcare, or related field can be substituted for 1 year of required experience.

Preferred Qualifications

Preferred Education
Master's

If Other Preferred Education, please specify

Discipline(s)

Certifications/Licenses Preferred
Certification in clinical research administration or compliance (e.g., CCRP, CCRC, CRA).

Indicate the preferred experience to perform the job
Experience in an academic medical center or health sciences research environment.

Posting Detail Information

Posting Number
U01521P

Number of Vacancies
1

Desired Start Date

Position End Date (if temporary)

Posting Close Date

Open Until Filled
Yes

Application Review Date to Begin

Special Instructions Summary

EEO Statement

LSU Health New Orleans seeks candidates who will contribute to a climate where students, faculty, and staff of all identities and backgrounds have equitable access and success opportunities. As an equal opportunity employer, we welcome all to apply without regard to race, color, religion, age, sex, national origin, physical or mental disability, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. LSU Health New Orleans is also designated as a State As a Model Employer (SAME) agency and provides assistance to persons needing accommodations or with the accessibility of materials. For those seeking such accommodations or assistance related to this search, we encourage you to contact the Office of Human Resource Management ( ).

About the School/Department

Comprehensive benefits are available to eligible employees and their dependents including health, life, dental, and vision insurance; flexible spending accounts; retirement plans; generous annual and sick leave; 14 paid holidays per year; and an employee health primary care clinic. See following link for more details on our benefits offerings: LSUHSC, New Orleans - Benefits

Other employee benefits include a full-service credit union, wellness benefits featuring complimentary fitness center membership for employees and their spouses, employee assistance program, campus assistance program, and pet insurance option. More information about these benefits can be found on this webpage: Additional Benefits

Clinical Trials Manager

The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Clinical Trials Manager to support our government client in Silver Spring, Maryland. This is not a remote position. The ideal candidate must be within reasonable commuting distance to provide onsite support.

Description of Responsibilities:

• Reports directly to the Program Manager.
• Manages all aspects of a clinical trial from pre-study to study close-out for entities such as drug companies, private physicians, academic institutions, and government agencies.
• Defines the trial budget and schedule.
• Reviews clinical research protocols for compliance, logistical support, and to ensure adequate staffing is available and scheduled appropriately.
• Oversees the screening and qualification of potential study subjects.
• Collects and reviews clinical data and ensures that all information needed to achieve the trial objective is obtained (i.e. review source documents, ensure data is entered correctly).
• Monitors progress of the trial and reports any issues to the trial director or physician.
• Trains, supervises, and tracks training requirements for trial staff and ensures that procedures are executed correctly.
• Reviews and updates all Standard Operating Procedures (SOPs) as required.
• Provides back-up coverage for any position to include but not limited to CRC, phlebotomist, recruiter, and administrative assistant.
• Provides and/or coordinates all contractually required reports.
• May be required to work evenings, weekends, and/or occasional nights. Typical work schedule is M-F 6:00AM - 2:30PM.
• Other duties as assigned by Supervisor.

Required Degree/Education/Certification:

• Registered Nurse with five (5) years of experience in Clinical Research.
• Maintain Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA).
• Basic Life Support (BLS -CPR/ AED) certification.

Required Skills and Experience:

• Solid regulatory-affairs experience is required, preferably related to vaccine research (i.e - Phase I vaccine prep/mixing).
• Must be able to work independently following a brief period of specific technical training.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
• Knowledge of applicable highly complex scientific procedures and techniques relating to position.

Desired Skills and Experience:

• Advanced Cardiac Life Support (ACLS) certification encouraged.

Required Citizenship and Clearance:

• Must be a U.S. Citizen
• Must be able to pass a background check for a NACI.

The Alakaina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Job Description

CLINICAL OPERATIONS: Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products.

Key Responsibilities:

• In partnership with Clinical Program Manager or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
• Communicates with functional peers regarding project status and issues and ensure project team goals are met
• Oversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out.
• Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report
• Coordinates data review to support interim/final data analysis
• Participates in study strategy development.
• Maintains study timelines.
• Contributes to development of study budget.
• Contributes to development of RFPs and participate in selection of CROs/vendors.
• Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, recruitment vendors, investigators and study coordinators on study requirements
• Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management).
• Proactively identifies potential study issues/risks and recommends/implements solutions.
• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
• May participates in the recruiting and hiring process for CTMs and supports their professional development
• May mentor other junior team members
• Coaches members of a work team and ensures adherence to established guidelines

Basic Qualifications

• BS/BA degree in nursing, science or health related field with at least 5 years of trial management experience - OR -
• MS/MA degree in nursing, science or health related field with at least 3 years of trial management experience

Preferred Qualifications

• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
• Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
• Highly developed leadership skills to successfully lead a clinical study team
• Ability to deal with time demands, incomplete information or unexpected events
• Must display strong analytical and problem solving skills
• Attention to detail
• Outstanding organizational skills with the ability to multi-task and prioritize
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
• Complete knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
• Familiar with standard medical / scientific terminology.
• Ability to communicate in a clear and concise manner.
• Ability to support a team-oriented, highly-matrixed environment.
• Ability to execute multiple tasks as assigned.
• When needed, ability to travel.

The salary range for this position is: $146,540.00 - $189,640.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:



* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Clinical Trials Manager to support our government client in Silver Spring, Maryland .

*This is not a remote position. The ideal candidate must be within reasonable commuting distance to provide onsite support.*

DESCRIPTION OF RESPONSIBILITIES:

• Reports directly to the Program Manager.
• Manages all aspects of a clinical trial from pre-study to study close-out for entities such as drug companies, private physicians, academic institutions, and government agencies.
• Defines the trial budget and schedule.
• Reviews clinical research protocols for compliance, logistical support, and to ensure adequate staffing is available and scheduled appropriately.
• Oversees the screening and qualification of potential study subjects.
• Collects and reviews clinical data and ensures that all information needed to achieve the trial objective is obtained (i.e. review source documents, ensure data is entered correctly).
• Monitors progress of the trial and reports any issues to the trial director or physician.
• Trains, supervises, and tracks training requirements for trial staff and ensures that procedures are executed correctly.
• Reviews and updates all Standard Operating Procedures (SOPs) as required.
• Provides back-up coverage for any position to include but not limited to CRC, phlebotomist, recruiter, and administrative assistant.
• Provides and/or coordinates all contractually required reports.
• May be required to work evenings, weekends, and/or occasional nights. Typical work schedule is M-F 6:00AM - 2:30PM.
• Other duties as assigned by Supervisor.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

• Registered Nurse with five (5) years of experience in Clinical Research.
• Maintain Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA).
• Basic Life Support (BLS -CPR/ AED) certification.

REQUIRED SKILLS AND EXPERIENCE:

• Solid regulatory-affairs experience is required, preferably related to vaccine research (i.e - Phase I vaccine prep/mixing).
• Must be able to work independently following a brief period of specific technical training.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
• Knowledge of applicable highly complex scientific procedures and techniques relating to position.

DESIRED SKILLS AND EXPERIENCE:

Advanced Cardiac Life Support (ACLS) certification encouraged.

REQUIRED CITIZENSHIP AND CLEARANCE:

• Must be a U.S. Citizen
• Must be able to pass a background check for a NACI.

The Alaka`na Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please click here to request accommodation. We E-Verify all employees

"EOE, including Disability/Vets" OR "Equal Opportunity Employer, including Disability/Veterans"

The Alaka ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke aki Technologies, Laulima Government Solutions, Kpono Government Services, and Kapili Services, Po okela Solutions, Kkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka ina Foundation activities under the 501(c)3 principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.

For additional information, please visit

#LI-JS1

#ClearanceJobs

#J-18808-Ljbffr

Posting Detail Information
Working TitleClinical Trials Coordinator
Position LocationFort Collins, CO
Work LocationPosition is fully in-office/in-person
Research Professional PositionNo
Posting Number202500649AP
Position TypeAdmin Professional/ Research Professional
Classification TitleResearch Associate II
Number of Vacancies
Work Hours/Week40
Proposed Annual Salary Range$50,000 - $60,000
Employee Benefits
Colorado State University is not just a workplace; it's a thriving community that's transforming lives and improving the human condition through world-class teaching, research, and service. With a robust benefits package, collaborative atmosphere, and focus on work-life balance, CSU is where you can thrive, grow, and make a lasting impact.
+ Review our detailed benefits information here. ( Explore the additional perks of working at CSU here.
+ For the total value of CSU benefits in addition to wages, use our compensation calculator ( .
+ Lastly, click here for more information about why Fort Collins is consistently ranked in the top cities to live in ( !
Desired Start Date
Position End Date (if temporary)
To ensure full consideration, applications must be received by 11:59pm (MT) on05/27/2025
Description of Work Unit
The Department of Clinical Sciences mission is to assure the health and productivity of animals to meet societal needs through high quality educational programs for professional veterinary medical students, graduate veterinarians, and the public through a faculty and veterinary medical center of excellence, and to advance and disseminate comparative biomedical knowledge in an environment of interdisciplinary collaboration.
Position Summary
The Flint Animal Cancer Center at Colorado State University is seeking applications to fill the position of Clinical Trials Coordinator. This position will manage protocol compliance for all enrolled clinical trials patients, assist in patient recruitment, provide assistance to the Clinical Trials Technician such as patient receiving, collecting samples and data entry, and perform various study-related administrative tasks such as shipping lab supply ordering and updating clinical trials patient rosters. This person is also responsible for maintaining study binders for all patients enrolled into clinical trials and ensuring that they are complete, as well as entering information into online data capture systems for clinical trials.
At this time, travel funds are limited for on-campus, in-person interviews.
The successful candidate must be legally authorized to work in the United States by the proposed start date; the department will not provide Visa sponsorship for this position.
Required Job Qualifications
+ BS degree in Biology or closely related field
OR
+ Associate degree with 2 years of related experience
AND
+ More than three years of experience as a veterinary technician or in human clinical trials
+ Previous experience working in a laboratory setting processing samples such as plasma, serum, peripheral blood mononuclear cells, etc.
+ Ability to work with others in a team environment
Preferred Job Qualifications
+ Demonstrated interest in clinical trials-related research.
+ Demonstrated excellent organization skills and attention to detail.
+ Preference will be given to candidates with previous experience in clinical trials.
Essential Duties
Job Duty CategoryProtocol Compliance
Duty/Responsibility
+ Ensure protocol compliance for all patients enrolled in clinical trials including internal monitoring of clinical trial data for quality and accuracy, sample collection/processing/shipment, and maintenance of patient study records.
+ Must maintain a working knowledge of protocols of all clinical trials that are open for enrollment.
Percentage Of Time55
Job Duty CategoryAdministrative
Duty/Responsibility
+ Completion of other administrative tasks as needed such as study drug inventory, study budget tracking, scheduling appointments for trials patients, updating the clinical trials patient enrollment roster, assembling patient binders, communications with Principal Investigators at CSU and other collaborating study sites, etc.
Percentage Of Time25
Job Duty CategoryStudy Participant Recruitment
Duty/Responsibility
+ Assist in clinical trial participant enrollment, including assessment of eligibility criteria and obtaining owner informed consent
Percentage Of Time10
Job Duty CategoryTechnician Assistant
Duty/Responsibility
+ Provide assistance to clinical trials technicians as needed
Percentage Of Time10
Application Details
Special Instructions to Applicants
This posting will remain open until filled. For full consideration, please apply by 5/27/2025, 11:59pm (MT). To apply, please upload a cover letter that addresses the required and preferred job qualifications, a resume, and the contact information for three professional references. References will not be contacted without prior notification to candidates.
CSU is committed to full inclusion of qualified individuals. If you are needing assistance or accommodations with the search process, please reach out to the listed search contact.
Please note, applicants may redact information from their application materials that identifies their age, date of birth, or dates of attendance at or graduation from an educational institution.
Conditions of EmploymentPre-employment Criminal Background Check (required for new hires)
Search
EEO
Colorado State University ( CSU ) provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Background Check Policy Statement
Colorado State University strives to provide a safe study, work, and living environment for its faculty, staff, volunteers and students. To support this environment and comply with applicable laws and regulations, CSU conducts background checks for the finalist before a final offer. The type of background check conducted varies by position and can include, but is not limited to, criminal history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will also be conducted when required by law or contract and when, in the discretion of the University, it is reasonable and prudent to do so.
References Requested
References Requested
Minimum Requested3
Maximum Requested3
Supplemental Questions
Required fields are indicated with an asterisk (*).
Applicant Documents
Required Documents
+ Cover Letter
+ Resume or CV
Optional Documents

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Job Description
**CLINICAL OPERATIONS:** Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products.
**Key Responsibilities:**
+ In partnership with Clinical Program Manager or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines
+ Communicates with functional peers regarding project status and issues and ensure project team goals are met
+ Oversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out.
+ Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report
+ Coordinates data review to support interim/final data analysis
+ Participates in study strategy development.
+ Maintains study timelines.
+ Contributes to development of study budget.
+ Contributes to development of RFPs and participate in selection of CROs/vendors.
+ Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, recruitment vendors, investigators and study coordinators on study requirements
+ Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management).
+ Proactively identifies potential study issues/risks and recommends/implements solutions.
+ Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
+ May participates in the recruiting and hiring process for CTMs and supports their professional development
+ May mentor other junior team members
+ Coaches members of a work team and ensures adherence to established guidelines
**Basic Qualifications**
+ BS/BA degree in nursing, science or health related field with at least 5 years of trial management experience - OR -
+ MS/MA degree in nursing, science or health related field with at least 3 years of trial management experience
**Preferred Qualifications**
+ Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
+ Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management
+ Highly developed leadership skills to successfully lead a clinical study team
+ Ability to deal with time demands, incomplete information or unexpected events
+ Must display strong analytical and problem solving skills
+ Attention to detail
+ Outstanding organizational skills with the ability to multi-task and prioritize
+ Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
+ Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
+ Complete knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
+ Familiar with standard medical / scientific terminology.
+ Ability to communicate in a clear and concise manner.
+ Ability to support a team-oriented, highly-matrixed environment.
+ Ability to execute multiple tasks as assigned.
+ When needed, ability to travel.
The salary range for this position is: $146,540.00 - $189,640.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION ( environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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

Clinical Trials Associate/ Sr Clinical Trials Assoc, Clinical Operations

Clinical Trials Associate (CTA), Clinical Operations, is responsible for supporting clinical study team(s) to manage various aspects of the operational execution and delivery of quality studies and quality processes according to protocols, SOPs, and Gossamer policies and procedures, applicable regulations and principles of GCP. The CTA will prioritize and handle multiple tasks effectively in a fast-paced Research and Development (R&D) environment. Either under the guidance of Clinical Operations management for the CTA or independently the Sr CTA, the individual will coordinate, track, and manage daily activities for multiple clinical studies to support both the internal project team(s) and the CRO(s).

Essential Duties and Responsibilities

CTA

• Assist in the tracking and oversight of all start-up activities (site and country study submissions, clinical trackers and essential documents status) and oversight of third-party vendors.
• Assist the Clinical Operations Manager(s)/Project Team to prepare and maintain eTMF, ensuring tracking of essential study documents and periodic review to assure accuracy and completeness.
• Support the Clinical Operations Manager(s) coordinating project meetings, including scheduling and drafting, distribution, and filing of meeting agendas and minutes.
• Communicate effectively with clinical study administration vendors (Functional Service providers etc.). Assist in coordination of Investigator and Vendor payments, tracking of invoices and accruals, if applicable.
• Assist in data listing review and clinical study report listing review.

Sr. CTA

• In addition to the above, will also be responsible for:
• Independently tracks and oversees study start-up activities and oversight of third-party vendors.
• Communicating key issues and mitigations to relevant cross-functional stakeholders.
• Leads the coordination of Investigator and Vendor payments, tracking of invoices and accruals, if applicable.
• Actively participates in data listing and/or clinical study report listing review.
• Contributes to creation of relevant study specific plans, tools and trackers.

Job Qualifications

Education, Certifications, Experience

CTA

• BA/BS in a relevant scientific discipline with 2+ years of experience in supporting clinical trial management for industry sponsored trials.
• Equivalent combination of education and 5+ years of experience in relevant clinical operations roles may be considered.

Sr. CTA

• BA/BS in a relevant scientific discipline with 3+ years of experience in supporting clinical trial management for industry sponsored trials.
• An equivalent combination of education and 6+ years of experience in relevant clinical operations roles may be considered.
• Experience being part of a Phase 3 global trial or Phase 2/3 rare disease programs is an asset.

Knowledge, Skills and Abilities

• Solid interpersonal skills and demonstrated ability to lead is required.
• Effective verbal, written, interpersonal and presentation skills are required.
• Working knowledge and experience with Word, PowerPoint, SharePoint and Excel.
• Strong attention to detail and dedication to accurate and high-quality work.
• Focus on results, highly collaborative cross functionally, and proactive.
• Effective time management skills and ability to manage competing priorities.
• Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.

Special Working Conditions

Office environment / Domestic and International travel may be necessary (up to 20%)

Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.

The expected salary range for this position is $87,000 to $135,000. Actual pay will be determined based on experience, qualifications, geographical location and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:

Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching, long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.

Clinical Trials Project Administrator

Are you interested in making a real scientific impact through your everyday work? Would you enjoy working in a team-focused environment as you explore unique career opportunities?

If you are looking for a company where you can personally advance healthcare and have influence in peoples lives with your bold ideas and unique points of view, consider working at Labcorp as a Clinical Trials Project Administrator.

In this role, you will manage and implement Phase I Clinical Trials Projects and Regional Projects. This role is also responsible for managing daily activities of established clinical trials.

In more details, you will

• Accountable for successful delivery of assigned clinical trials projects. Ensure that study specifications and deliverables are consistent with corporate and client expectations. Ensures that scope and timelines are clearly documented and agreed, according to client, protocol, and internal requirements.
• Coordinates and implements plans associated with logistics, specimen management, data management and laboratory operations, as required. Coordinates timelines and resource requirements with other functional areas
• Ensures that validation and quality control requirements are fulfilled and documented on time and in accordance with standard operating procedures. Ensure all required internal and client approvals are obtained.
• Organizes any client meetings and/or training sessions as required to communicate study requirements internally and externally. Documents all required study training in project files.
• Provides daily management of the project through internal and external co-ordination and follow-up during the project life cycle.
• Interacts with project team members to resolve and troubleshoot problems related to specimens, result reporting and site compliance. Provides clients with resolutions to problems or referral to appropriate sources.
• Status reporting and reviews of assigned projects through data management tools and regular Project Team meetings. Provides additional updates and metrics as required for the management team.
• Proactively manages and anticipates risks to successful project delivery and escalates issues promptly in accordance with global escalation policy.
• Maintains clear and frequent communication with the client and management team to provide project status updates.
• Manages manual invoicing activities to ensure these aspects are always aligned.
• Interact with Quality Assurance members when need to participate in audits, inspections, and other QA/QC issues. Respond promptly to requests for information associated with these activities.
• Completes all tasks in accordance with standard operating procedures and policies and assists in assuring ongoing compliance within the project team. Maintains an up-to-date personnel file including all required training documentation.
• Performs any other duties assigned by the management team including, but not limited to, process improvement/standardization projects and SOP development and reviews.

Thrive personally and professionally at Labcorp

Working at Labcorp, you will continue to grow in our learning-based culture, so you will know how to respond and adapt expertly as the industry continues to evolve. Here, you will put your education to work as you play a meaningful role in advancing healthcare and making a difference in peoples lives.

In addition, Labcorp offers great benefits, global experience, and the opportunity to work independently within a collaborative environment.

What we are looking for

Clinical Trials Project Administrator are the most successful at Labcorp with:

• Bachelors Degree or work experience equivalent in science, laboratory, or health related disciplines (or equivalent combination of education and experience in a clinical trials environment, at least 5 years) preferred.
• Exceptional written and verbal communication skills
• Strong organizational abilities
• Keen attention to detail
• Effective time management and prioritization
• Strong negotiation and presentation skills
• Ability to effectively solve problems strongly preferred

Get to know Labcorp

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations.

Here, you can join our more than 60,000 employees, serving clients in more than one hundred countries, as we work together to make a real impact on peoples lives.

Pay Range: $80 - $100,000

Application Window Open Through: 27Aug25

Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only.

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.