Clinical Trials Manager (Oncology)
Exelixis
3 days ago
On-site
Alameda, CA
Clinical Research and Development
Clinical Trials Manager (CTM), Clinical Operations – coordinates the activities for evaluation, initiation, and management of solid tumor oncology clinical trials. Oversees trial execution, CRO oversight, and provides operational support to the Study Delivery Lead (SDL).
Responsibilities:
- Manage clinical trials, including those run through CROs
- Participate in operational strategy development with cross-functional teams
- Own a geographic region; manage 1–3 external vendors within scope (e.g., lab)
- Engage with CROs/vendors/sites for trial execution; manage relationships and provide quality/performance oversight
- Provide CRO oversight for site start-up/maintenance (trip reports, protocol deviations, data review, etc.)
- Contribute to Study Delivery Team meetings (agenda prep)
- Coordinate Investigator Meetings (prep, conduct, presentations)
- Support feasibility assessments and site selection with SDT/CRO
- Support protocol development; review ICFs, CRFs, monitoring plans, and other study materials
- Maintain regular contact with Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.
- Ensure site adherence to protocol and ICH-GCP; proactively identify/escalate issues with risk mitigation
- Ensure oversight of regulatory and essential documents
- Support study plan/document development (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specs, user manuals)
- Coordinate study guides and subject instructions; review study trackers/metrics
- Provide oversight of study documents (protocol, ICF, CRFs, IRT specs, labels, etc.)
- May review site/vendor invoices; may mentor and train Sr. Clinical Trial Specialists
Qualifications:
- BA/BSN (biological sciences or related) + 7+ years related experience; or MS/MA/MSN + 5+ years; or PhD/PharmD + 0+ years; or equivalent
- Minimum 7 years in life sciences with 5 years in clinical research
Skills/Experience:
- Experience across start-up, maintenance, or close-out
- Prospective site-selection criteria development; protocol development
- Working knowledge of ICH-GCP, local regulations, SOPs, study procedures
- Vendor/CRO experience; review site proposed ICs for regulatory compliance
- Ability to write/present on scientific and clinical issues; strong organization, planning, communication, interpersonal skills
- Ability to work in matrix/team environments and solve problems
Benefits:
- 401(k) with generous company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts; discretionary annual bonus (or sales incentive plan for field sales); company stock; long-term incentives; 15 vacation days; 17 paid holidays (incl. winter shutdown); up to 10 sick days.
Application instructions:
- If you have a disability and need an accommodation in relation to the application and/or recruitment process, email recruiting@exelixis.com.
Responsibilities:
- Manage clinical trials, including those run through CROs
- Participate in operational strategy development with cross-functional teams
- Own a geographic region; manage 1–3 external vendors within scope (e.g., lab)
- Engage with CROs/vendors/sites for trial execution; manage relationships and provide quality/performance oversight
- Provide CRO oversight for site start-up/maintenance (trip reports, protocol deviations, data review, etc.)
- Contribute to Study Delivery Team meetings (agenda prep)
- Coordinate Investigator Meetings (prep, conduct, presentations)
- Support feasibility assessments and site selection with SDT/CRO
- Support protocol development; review ICFs, CRFs, monitoring plans, and other study materials
- Maintain regular contact with Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.
- Ensure site adherence to protocol and ICH-GCP; proactively identify/escalate issues with risk mitigation
- Ensure oversight of regulatory and essential documents
- Support study plan/document development (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specs, user manuals)
- Coordinate study guides and subject instructions; review study trackers/metrics
- Provide oversight of study documents (protocol, ICF, CRFs, IRT specs, labels, etc.)
- May review site/vendor invoices; may mentor and train Sr. Clinical Trial Specialists
Qualifications:
- BA/BSN (biological sciences or related) + 7+ years related experience; or MS/MA/MSN + 5+ years; or PhD/PharmD + 0+ years; or equivalent
- Minimum 7 years in life sciences with 5 years in clinical research
Skills/Experience:
- Experience across start-up, maintenance, or close-out
- Prospective site-selection criteria development; protocol development
- Working knowledge of ICH-GCP, local regulations, SOPs, study procedures
- Vendor/CRO experience; review site proposed ICs for regulatory compliance
- Ability to write/present on scientific and clinical issues; strong organization, planning, communication, interpersonal skills
- Ability to work in matrix/team environments and solve problems
Benefits:
- 401(k) with generous company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts; discretionary annual bonus (or sales incentive plan for field sales); company stock; long-term incentives; 15 vacation days; 17 paid holidays (incl. winter shutdown); up to 10 sick days.
Application instructions:
- If you have a disability and need an accommodation in relation to the application and/or recruitment process, email recruiting@exelixis.com.