Clinical Trials Manager (Biotechnology, Oncology)
Exelixis
June 24, 2026
Remote friendly (Alameda, CA)
United States
Clinical Research and Development
Summary/Job Purpose
- The Clinical Trials Manager (CTM), Clinical Operations coordinates the evaluation, initiation, and management of clinical trials, overseeing execution, CRO oversight, and operational support to the Study Delivery Lead (SDL).
Essential Duties and Responsibilities
- Manage clinical trials (including CRO-conducted trials).
- Engage with CROs, vendors, and sites for execution; manage relationships and ensure quality/performance.
- Provide CRO oversight for site start-up/maintenance (trip reports, protocol deviations, data review).
- Attend internal Study Delivery Team (SDT) meetings and support agenda preparation.
- Coordinate Investigator Meetings (prep, conduct, presentations).
- Support feasibility assessments and site selection with SDT/CRO.
- Support protocol development and review: ICFs, CRFs, monitoring plans, and other study materials.
- Coordinate with Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.
- Ensure site adherence to protocol and ICH-GCP; identify issues, mitigate risks, and escalate.
- Oversee regulatory/essential documents and development of study plans (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specs, User Manuals).
- Coordinate study guide/subject instruction design.
- May support governance and invoice reviews; review study trackers/metrics; oversee protocol/ICF/CRF/IRT/label reviews.
- May mentor/train Sr. Clinical Trial Specialists.
Supervisory Responsibilities
- None.
Education/Experience
- BA/BSN (bio or related) + 7 years; or MS (bio) + 5 years; or PhD/PharmD (bio) + 0+ years; or equivalent.
- Typically 7+ years life sciences, including 5 years clinical research.
Required/Preferred Skills & Knowledge
- Clinical trial start-up, maintenance, or close-out experience.
- Prospective site-selection criteria development; protocol development.
- Working knowledge of ICH-GCP, local regulations, SOPs, and study procedures.
- Vendor/CRO and contract lab experience; site IC adequacy review.
- Clear scientific/clinical writing and presentations; strong organization, planning, communication, and matrix teamwork; problem-solving.
Working Conditions
- Travel up to 20%.
Benefits (as stated)
- 401(k), medical/dental/vision, life/disability, flexible spending; discretionary annual bonus (or sales incentive for field sales); stock purchase; long-term incentives; 15 vacation days (year 1), 17 paid holidays (incl. winter shutdown), up to 10 sick days.
- The Clinical Trials Manager (CTM), Clinical Operations coordinates the evaluation, initiation, and management of clinical trials, overseeing execution, CRO oversight, and operational support to the Study Delivery Lead (SDL).
Essential Duties and Responsibilities
- Manage clinical trials (including CRO-conducted trials).
- Engage with CROs, vendors, and sites for execution; manage relationships and ensure quality/performance.
- Provide CRO oversight for site start-up/maintenance (trip reports, protocol deviations, data review).
- Attend internal Study Delivery Team (SDT) meetings and support agenda preparation.
- Coordinate Investigator Meetings (prep, conduct, presentations).
- Support feasibility assessments and site selection with SDT/CRO.
- Support protocol development and review: ICFs, CRFs, monitoring plans, and other study materials.
- Coordinate with Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.
- Ensure site adherence to protocol and ICH-GCP; identify issues, mitigate risks, and escalate.
- Oversee regulatory/essential documents and development of study plans (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specs, User Manuals).
- Coordinate study guide/subject instruction design.
- May support governance and invoice reviews; review study trackers/metrics; oversee protocol/ICF/CRF/IRT/label reviews.
- May mentor/train Sr. Clinical Trial Specialists.
Supervisory Responsibilities
- None.
Education/Experience
- BA/BSN (bio or related) + 7 years; or MS (bio) + 5 years; or PhD/PharmD (bio) + 0+ years; or equivalent.
- Typically 7+ years life sciences, including 5 years clinical research.
Required/Preferred Skills & Knowledge
- Clinical trial start-up, maintenance, or close-out experience.
- Prospective site-selection criteria development; protocol development.
- Working knowledge of ICH-GCP, local regulations, SOPs, and study procedures.
- Vendor/CRO and contract lab experience; site IC adequacy review.
- Clear scientific/clinical writing and presentations; strong organization, planning, communication, and matrix teamwork; problem-solving.
Working Conditions
- Travel up to 20%.
Benefits (as stated)
- 401(k), medical/dental/vision, life/disability, flexible spending; discretionary annual bonus (or sales incentive for field sales); stock purchase; long-term incentives; 15 vacation days (year 1), 17 paid holidays (incl. winter shutdown), up to 10 sick days.