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Clinical Trials Manager
2 months ago
Gilead Sciences is seeking a highly skilled Clinical Trials Manager to join our team in Foster City, California. As a Clinical Trials Manager, you will be responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas.
Key Responsibilities:- Manage all components of small clinical studies, including Phase I studies.
- Manage actively clinical study budgets and exercises proactive financial oversight.
- Collaborate with other functions on how to best achieve their study goals and objectives and communicates cross-functionally to ensure project team goals are met.
- With guidance, may lead contract research organization (CRO) and vendor selection and, where applicable, oversees and/or manages interactions and deliverables from relevant CROs, subcontractors, and vendors.
- Typically serves as the key operational contact for Gilead studies, providing oversight for the site evaluation, initiation, and close-out visits in addition to conducting oversight monitoring visits,
- Defines study logistics and oversees/develops clinical study plans for assigned clinical studies.
- Manages study timelines, including documentation and communications.
- Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams as appropriate.
- Contributes to SOP development and/or participates in special projects. Develops tools and processes that optimize project efficiencies and effectiveness.
- Provides input into study protocols, case report forms, and informed consents, oversees/authors study plans, and presentations.
- Provides oversight of study sites/region and reviews routine regulatory documents to ensure that CROs/vendors are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
- Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.
- May be required to present at internal or external meetings (i.e., investigator meetings).
- Leads or otherwise assists in the preparation of safety, interim and final study reports, including resolving any data discrepancies.
- Proactively identifies potential operational challenges and collaborates with other Clinical Operations' colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.
- Assists in training new or less experienced colleagues.
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements
- MA/MS/PharmD/PhD with 3+ years' relevant clinical or related experience in life sciences.
- BA/BS/RN with 5+ years' relevant clinical or related experience in life sciences.
- Multiple years' clinical or related experience in life sciences, including experience leading or managing less complex studies and project teams.
- Experience managing the work of external vendors.
Gilead Sciences offers a competitive salary range of $143,000 - $185,000, depending on experience, qualifications, and geographic location. 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.
Gilead Sciences is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees. If you require accommodation during the application process, please contact us at [insert contact information].
