Clinical Trials Manager (Biotechnology, Oncology)
Exelixis
July 01, 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, including oversight of CRO activities and operational support to the Study Delivery Lead (SDL).
Essential Duties and Responsibilities
- Manages clinical trials (including via CROs) and supports operational strategy with cross-functional teams.
- Owns at least one geographical region; manages 1–3 external vendors (e.g., lab) within scope.
- Partners with CROs/vendors/sites for execution, relationship management, and quality/performance oversight.
- Provides CRO oversight for site start-up/maintenance (trip reports, protocol deviations, data review) and ensures protocol/GCP adherence.
- Supports investigator meetings (coordination, conduct, presentations) and feasibility/site-selection activities.
- Assists protocol development; reviews ICFs, CRFs, monitoring plans, and other study materials.
- Maintains contact with Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.
- Oversees regulatory/essential documents; supports development of study plans (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specs, user manuals).
- Reviews study trackers/metrics; reviews study documents (protocol/ICF/CRF/labels/IRT specs).
- May mentor/training Sr. Clinical Trial Specialists (CTS).
Education/Experience
- BA/BSN (biological sciences or related) + 7+ years; or MS (or equivalent) + 5+ years; or PhD/PharmD + 0+ years; or equivalent combination.
Required/Preferred Knowledge & Skills
- Experience in study start-up, maintenance, or close-out; prospective site-selection criteria; protocol development.
- Working knowledge of ICH-GCP, local regulations, SOPs, and study procedures.
- Vendor/CRO interactions; review site IC adequacy; strong scientific/clinical writing and presentation.
- Organizational/planning, communication, matrix teamwork, problem-solving.
Working Conditions
- Travel up to 20%.
Benefits (as stated)
- Comprehensive medical/dental/vision, life/disability, flexible spending accounts; 401(k) with company contributions; discretionary annual bonus; stock purchase; paid vacation/holidays and sick days.
The Clinical Trials Manager (CTM), Clinical Operations coordinates the evaluation, initiation, and management of clinical trials, including oversight of CRO activities and operational support to the Study Delivery Lead (SDL).
Essential Duties and Responsibilities
- Manages clinical trials (including via CROs) and supports operational strategy with cross-functional teams.
- Owns at least one geographical region; manages 1–3 external vendors (e.g., lab) within scope.
- Partners with CROs/vendors/sites for execution, relationship management, and quality/performance oversight.
- Provides CRO oversight for site start-up/maintenance (trip reports, protocol deviations, data review) and ensures protocol/GCP adherence.
- Supports investigator meetings (coordination, conduct, presentations) and feasibility/site-selection activities.
- Assists protocol development; reviews ICFs, CRFs, monitoring plans, and other study materials.
- Maintains contact with Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.
- Oversees regulatory/essential documents; supports development of study plans (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specs, user manuals).
- Reviews study trackers/metrics; reviews study documents (protocol/ICF/CRF/labels/IRT specs).
- May mentor/training Sr. Clinical Trial Specialists (CTS).
Education/Experience
- BA/BSN (biological sciences or related) + 7+ years; or MS (or equivalent) + 5+ years; or PhD/PharmD + 0+ years; or equivalent combination.
Required/Preferred Knowledge & Skills
- Experience in study start-up, maintenance, or close-out; prospective site-selection criteria; protocol development.
- Working knowledge of ICH-GCP, local regulations, SOPs, and study procedures.
- Vendor/CRO interactions; review site IC adequacy; strong scientific/clinical writing and presentation.
- Organizational/planning, communication, matrix teamwork, problem-solving.
Working Conditions
- Travel up to 20%.
Benefits (as stated)
- Comprehensive medical/dental/vision, life/disability, flexible spending accounts; 401(k) with company contributions; discretionary annual bonus; stock purchase; paid vacation/holidays and sick days.