Clinical Trials Manager, Early Phase Oncology (Office Based)

About the role

We are seeking a Clinical Trials Manager (CTM) to support the Early Phase Oncology pipeline. The CTM drives end-to-end operational delivery of early-phase oncology trials, ensuring high-quality execution through strong cross-functional leadership and CRO/vendor oversight.

Responsibilities

• Coordinating and supervising all aspects of clinical study.
• Assists Clinical Program Manager in the overall study management.
• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
• Maintains study timelines.
• Contributes to development of study budget.
• Contributes to development of RFPs and participates in selection of CROs/vendors.
• Manage CROs/vendors.
• Coordinates review of data listings and preparation of interim/final clinical study reports.
• May contribute to development of abstracts, presentations, and manuscripts.
• Ensures effectiveness of site budget/contract process.
• May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
• Aids in determining the activities to support a project’s priorities within functional area.
• Under supervision, designs scientific communications within the company.
• Travel is required.
• Excellent teamwork, communication, decision-making and organizational skills are required.
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• Must be able to generally understand, interpret, and explain protocol requirements to others.
• Must be able to prioritize multiple tasks.
• May serve as a resource for others within the company for clinical trials management expertise.
• Under general supervision, examines functional issues from an organizational perspective.
• Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
• Has general, functional expertise to support SOP development and implementation.

Requirements

• Bachelor's Degree and Five Years’ Experience in a relevant scientific discipline.
• ORMasters' Degree and Three Years’ Experience in a relevant scientific discipline.

Qualifications

• Prior CRO/Pharma experience REQUIRED.
• Prior Oncology experience REQUIRED.
• Early Development/Early Phase Oncology experience preferred but not REQUIRED.

Skills

• Strong project management, clinical, and regulatory expertise.

Benefits

• The Salary Range For This Position Is Bay Area: $146,540.00 - $189,640.00.
• Other US Locations: $133,195.00 - $172,370.00.
• Gilead considers a variety of factors when determining base compensation, including 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.