Clinical Trials Manager

Gilead Sciences • Foster City, CA

2d

About The Position

The Clinical Trials Manager manages a geographical region of assigned clinical studies, multiple components of larger studies, or all components of small clinical studies, including Phase 1 studies. The role includes active management of clinical study budgets and proactive financial oversight, collaboration across functions, and communication to ensure project team goals are met. With guidance, the manager may lead CRO and vendor selection and oversee or manage their interactions and deliverables.

The position typically serves as the key operational contact for Gilead studies, overseeing site evaluation, initiation, close-out, and monitoring visits. It defines study logistics and oversees or develops clinical study plans, manages study timelines and related documentation and communications, and may act as a Business Lead for initiatives or projects. The manager contributes to SOP development and special projects, develops tools and processes to improve project efficiency, provides input into protocols, case report forms, and informed consents, and oversees or authors study plans and presentations.

The manager oversees study sites or regions and reviews routine regulatory documents to ensure compliance with protocols, regulatory requirements, SOPs, and monitoring plans. The role is responsible for affiliate Clinical Operations activities required by local regulations or usual practice, may present at internal or external meetings, and leads or assists with safety, interim, and final study reports, including resolving data discrepancies. The manager identifies operational challenges and works with Clinical Operations colleagues to keep study execution on track with protocols, budgets, and timelines, assists in training less experienced colleagues, and ensures their work complies with established practices, policies, processes, and applicable requirements.

Requirements

• BA, BS, or RN with 5 or more years of relevant clinical or related experience in life sciences; or 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 exercise proactive financial oversight.
• Collaborate and communicate cross-functionally to help ensure project team goals and objectives are met.
• With guidance, lead CRO and vendor selection and oversee or manage interactions and deliverables from CROs, subcontractors, and vendors, as applicable.
• Serve as a key operational contact for Gilead 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, and manage project meetings and conference calls with vendors and cross-functional teams as appropriate.
• Contribute to SOP development and participate in special projects.
• Develop tools and processes to optimize 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 for compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
• Manage affiliate Clinical Operations activities required by local regulations or usual practice to support clinical trials.
• Present at internal or external meetings, such as investigator meetings, when required.
• Lead or assist with preparation of safety, interim, and final study reports, including resolution of data discrepancies.
• Identify operational challenges and collaborate with Clinical Operations colleagues on solutions to keep study execution on track with defined protocols, budgets, and timelines.
• Assist in training new or less experienced colleagues.
• Ensure own 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, dental, vision, and life insurance plans.

What This Job Offers

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