Clinical Trials Manager
Gilead Sciences
9 hours ago
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Clinical Operations is responsible for the worldwide execution of Phase I–IV clinical trials across all Gilead therapeutic areas. Ensures trials are performed in accordance with applicable SOPs, company policies, and regulatory guidelines to provide timely, high-quality clinical data. Typically manages Late Phase and Observational Research studies; defines/incorporates study logistics and study plans; may participate in strategic initiatives/projects.
This is a site-based position (Tuesday–Thursday) at our Foster City, CA campus.
Responsibilities
- Manage assigned clinical studies/regions and study components (Late Phase and Observational Research).
- Manage clinical study budgets with proactive financial oversight.
- Collaborate cross-functionally to meet study goals.
- Lead (with guidance) CRO and vendor selection; train/oversee deliverables and interactions.
- Serve as key operational contact; oversee site evaluation, initiation, close-out, and conduct monitoring visits.
- Define study logistics; oversee/develop clinical study plans.
- Manage study timelines, documentation, and communications.
- Participate/act as Business Lead; manage meetings/calls with CROs, vendors, and cross-functional teams.
- Contribute to SOP development/special projects; develop tools/processes to improve efficiencies.
- Provide input to protocols, case report forms, informed consents, study reports, and presentations.
- Coordinate data listing review and interim/final report preparation.
- Oversee study sites/region; review regulatory documents for CRO/vendor compliance.
- Lead or assist safety/interim/final report preparation; resolve data discrepancies.
- Identify operational challenges and develop solutions; assist training others.
Minimum Education & Experience
- MA/MS/PharmD/PhD with 3+ years relevant clinical/related life sciences experience; or
- BA/BS/RN with 5+ years; plus experience leading/managing complex studies/projects.
- Experience managing CROs and external vendors.
Knowledge & Other Requirements
- Fast learner; flexible/adaptable; ability to manage full cycle study management.
- Advanced study management best practices/tools; understand and interpret protocol requirements.
- Knowledge of FDA/EMEA/national regulations, ICH, GCP; familiar with medical/scientific terminology.
- Clear communication; team-oriented in a highly matrixed environment; execute multiple tasks; travel as needed.
Benefits/Compensation
- Salary range: $146,540.00–$189,640.00; may include discretionary annual bonus, stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application
- Apply via the Internal Career Opportunities portal in Workday.
This is a site-based position (Tuesday–Thursday) at our Foster City, CA campus.
Responsibilities
- Manage assigned clinical studies/regions and study components (Late Phase and Observational Research).
- Manage clinical study budgets with proactive financial oversight.
- Collaborate cross-functionally to meet study goals.
- Lead (with guidance) CRO and vendor selection; train/oversee deliverables and interactions.
- Serve as key operational contact; oversee site evaluation, initiation, close-out, and conduct monitoring visits.
- Define study logistics; oversee/develop clinical study plans.
- Manage study timelines, documentation, and communications.
- Participate/act as Business Lead; manage meetings/calls with CROs, vendors, and cross-functional teams.
- Contribute to SOP development/special projects; develop tools/processes to improve efficiencies.
- Provide input to protocols, case report forms, informed consents, study reports, and presentations.
- Coordinate data listing review and interim/final report preparation.
- Oversee study sites/region; review regulatory documents for CRO/vendor compliance.
- Lead or assist safety/interim/final report preparation; resolve data discrepancies.
- Identify operational challenges and develop solutions; assist training others.
Minimum Education & Experience
- MA/MS/PharmD/PhD with 3+ years relevant clinical/related life sciences experience; or
- BA/BS/RN with 5+ years; plus experience leading/managing complex studies/projects.
- Experience managing CROs and external vendors.
Knowledge & Other Requirements
- Fast learner; flexible/adaptable; ability to manage full cycle study management.
- Advanced study management best practices/tools; understand and interpret protocol requirements.
- Knowledge of FDA/EMEA/national regulations, ICH, GCP; familiar with medical/scientific terminology.
- Clear communication; team-oriented in a highly matrixed environment; execute multiple tasks; travel as needed.
Benefits/Compensation
- Salary range: $146,540.00–$189,640.00; may include discretionary annual bonus, stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application
- Apply via the Internal Career Opportunities portal in Workday.