Clinical Trials Manager- Late Phase Oncology (Office-Based)
Gilead Sciences
5 days ago
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Job Summary
Clinical Trials Manager (CTM) to support the Oncology pipeline, driving end-to-end operational delivery of Phase II/III oncology trials through cross-functional leadership and CRO/vendor oversight. Ensures study execution, alignment across stakeholders, proactive risk identification, solutions implementation, and timeline maintenance for in-house and/or hybrid trials.
Key Responsibilities
- Coordinate and supervise all aspects of clinical studies; assist Clinical Program Manager in overall study management.
- Provide input into protocols, investigator brochures, case report forms, informed consents, final study reports; oversee/author study plans and presentations.
- Maintain study timelines (documentation and communications); contribute to study budgets and RFP development; participate in CRO/vendor selection.
- May manage CROs/vendors; may serve as key operational contact for site evaluation, initiation, close-out, and oversight monitoring visits.
- Review regulatory documents to ensure compliance with protocols, regulatory requirements, SOPs, and monitoring plans; ensure site budget/contract effectiveness.
- May train CROs/vendors/investigators/study coordinators; coordinate data listing review and interim/final reports (resolve discrepancies).
- Develop tools/processes to improve efficiencies; travel required; strong teamwork, communication, decision-making, and organizational skills.
Basic Qualifications
- 5+ years with BS/BA in a relevant scientific discipline.
- 3+ years with MS/MA in a relevant scientific discipline.
- Prior Oncology experience and prior CRO/Pharma/Biotech experience required.
Preferred/Desirable
- FDA/EMEA regulations, ICH guidelines, and GCP knowledge desirable; ability to interpret/explain protocol requirements.
People Leader Accountabilities
- Create Inclusion; Develop Talent; Empower Teams.
Location
Foster City, CA or Parsippany, NJ.
Compensation/Benefits (as stated)
- Bay Area: $146,540.00–$189,640.00; Other US locations: $133,195.00–$172,370.00. Eligible for discretionary bonus/long-term incentives; paid time off and benefits including medical/dental/vision/life insurance.
Application Instructions
For current Gilead employees/contractors: apply via the Internal Career Opportunities portal in Workday.
Clinical Trials Manager (CTM) to support the Oncology pipeline, driving end-to-end operational delivery of Phase II/III oncology trials through cross-functional leadership and CRO/vendor oversight. Ensures study execution, alignment across stakeholders, proactive risk identification, solutions implementation, and timeline maintenance for in-house and/or hybrid trials.
Key Responsibilities
- Coordinate and supervise all aspects of clinical studies; assist Clinical Program Manager in overall study management.
- Provide input into protocols, investigator brochures, case report forms, informed consents, final study reports; oversee/author study plans and presentations.
- Maintain study timelines (documentation and communications); contribute to study budgets and RFP development; participate in CRO/vendor selection.
- May manage CROs/vendors; may serve as key operational contact for site evaluation, initiation, close-out, and oversight monitoring visits.
- Review regulatory documents to ensure compliance with protocols, regulatory requirements, SOPs, and monitoring plans; ensure site budget/contract effectiveness.
- May train CROs/vendors/investigators/study coordinators; coordinate data listing review and interim/final reports (resolve discrepancies).
- Develop tools/processes to improve efficiencies; travel required; strong teamwork, communication, decision-making, and organizational skills.
Basic Qualifications
- 5+ years with BS/BA in a relevant scientific discipline.
- 3+ years with MS/MA in a relevant scientific discipline.
- Prior Oncology experience and prior CRO/Pharma/Biotech experience required.
Preferred/Desirable
- FDA/EMEA regulations, ICH guidelines, and GCP knowledge desirable; ability to interpret/explain protocol requirements.
People Leader Accountabilities
- Create Inclusion; Develop Talent; Empower Teams.
Location
Foster City, CA or Parsippany, NJ.
Compensation/Benefits (as stated)
- Bay Area: $146,540.00–$189,640.00; Other US locations: $133,195.00–$172,370.00. Eligible for discretionary bonus/long-term incentives; paid time off and benefits including medical/dental/vision/life insurance.
Application Instructions
For current Gilead employees/contractors: apply via the Internal Career Opportunities portal in Workday.