Clinical Trials Manager

Gilead Sciences • Foster City, CA

1d • $146,540 - $189,640

About The Position

The Clinical Trials Manager manages assigned clinical studies across a geographical region, multiple components of larger studies, or all components of smaller studies, including Phase 1 studies. The role manages study budgets and timelines, coordinates with cross-functional teams, and oversees study logistics, sites, CROs, subcontractors, and vendors. It serves as a key operational contact for Gilead studies and helps ensure studies are conducted in accordance with protocols, budgets, timelines, SOPs, and regulatory requirements.

The position contributes to study plans, protocols, case report forms, informed consents, reports, presentations, SOP development, and process-improvement initiatives. It may lead or support project initiatives, vendor selection, investigator meetings, and training of colleagues. The manager proactively identifies operational challenges and collaborates with Clinical Operations colleagues to keep study execution on track.

Requirements

• BA, BS, or RN with 5 or more years of relevant clinical or related experience in life sciences; alternatively, MA, MS, PharmD, or PhD with 3 or more years of relevant clinical or related experience in life sciences.
• Multiple years of 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.

Responsibilities

• Manage a geographical region of assigned clinical studies, multiple components of larger studies, or all components of small studies, including Phase 1 studies.
• Actively manage clinical study budgets and provide proactive financial oversight.
• Collaborate and communicate with other functions to achieve study goals and project-team objectives.
• With guidance, lead CRO and vendor selection and oversee or manage their interactions and deliverables where applicable.
• Serve as a key operational contact for studies and oversee site evaluation, initiation, close-out, and monitoring visits.
• Define study logistics and oversee or develop clinical study plans.
• Manage study timelines, documentation, and communications.
• Participate in or act as a Business Lead for initiatives and projects; manage meetings and conference calls with CROs, vendors, and cross-functional teams as appropriate.
• Contribute to SOP development and special projects, and develop tools and processes to improve project efficiency and effectiveness.
• Provide input into study protocols, case report forms, and informed consents; oversee or author study plans and presentations.
• Oversee study sites or regions and review routine regulatory documents to ensure CRO and vendor compliance with protocols, regulations, SOPs, and monitoring plans.
• Conduct Clinical Operations activities required of the affiliate by local regulations or usual practice to support clinical trials.
• Present at internal or external meetings, such as investigator meetings, as required.
• Lead or assist with preparation of safety, interim, and final study reports, including resolving data discrepancies.
• Identify operational challenges and collaborate with Clinical Operations colleagues on solutions to keep study execution aligned with protocols, budgets, and timelines.
• Assist in training new or less experienced colleagues.
• Ensure work complies with established practices, policies, processes, and regulatory or other requirements.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level