Clinical Trials Manager (Biotechnology, Oncology)
Exelixis
20 days ago
Remote friendly (Alameda, CA)
United States
Clinical Research and Development
Summary/Job Purpose:
The Clinical Trials Manager (CTM), Clinical Operations coordinates the activities associated with the evaluation, initiation, and management of clinical trials. Oversees execution of clinical trials, collaborates with cross-functional teams, provides oversight of Contract Research Organizations (CROs), and provides operational support to the Study Delivery Lead (SDL).
Essential Duties and Responsibilities:
- Manages clinical trials, including those through CROs
- Participates in developing operational strategies in collaboration with cross-functional teams
- Responsible for at least one geographical region; manages/oversees 1–3 external vendors (e.g., Lab)
- Engages CROs/vendors/sites for trial execution; manages relationships and ensures quality/performance
- Provides CRO oversight for site start-up/maintenance (trip reports, protocol deviations, data review, etc.)
- Contributes to internal Study Delivery Team (SDT) meetings; supports agenda preparation
- Coordinates preparation, conduct, and presentations at Investigator Meetings
- Assists feasibility assessments and site selection
- Supports protocol development; reviews informed consent forms, case report forms, monitoring plans, and other study materials
- Maintains contact with Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.
- Ensures oversight of regulatory and essential documents; supports development of study plans/documents (VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specs, User Manuals)
- Reviews and oversees study trackers/metrics; oversees development/review of core study documents (Protocol, ICF, CRFs, IRT specs, labels, etc.)
- Identifies/escalates issues; provides risk mitigation strategies
- May mentor and provide training to Sr. Clinical Trial Specialists (CTS)
- May support/own site and vendor invoice reviews
- Travel may be required up to 20%
Supervisory Responsibilities: None
Education/Experience:
- BA/BSN (biological sciences or related) + 7+ years related experience; or MS + 5+; or PhD/PharmD + 0+; or equivalent combination.
- Typically 7+ years life sciences related experience, including 5 years in clinical research.
Knowledge/Skills:
- Experience in study start-up, maintenance, or close-out
- Prospective site-selection criteria development
- Protocol development experience
- Working knowledge and compliance with ICH-GCP, local regulations, SOPs, and study procedures
- Vendor (CRO/lab) interaction experience; oversight of site-proposed ICs for regulatory compliance
- Ability to write/present clearly on scientific/clinical topics; strong organization, communication, interpersonal, and problem-solving skills
- Ability to work in a matrix/team environment and understand technical/medical information
The Clinical Trials Manager (CTM), Clinical Operations coordinates the activities associated with the evaluation, initiation, and management of clinical trials. Oversees execution of clinical trials, collaborates with cross-functional teams, provides oversight of Contract Research Organizations (CROs), and provides operational support to the Study Delivery Lead (SDL).
Essential Duties and Responsibilities:
- Manages clinical trials, including those through CROs
- Participates in developing operational strategies in collaboration with cross-functional teams
- Responsible for at least one geographical region; manages/oversees 1–3 external vendors (e.g., Lab)
- Engages CROs/vendors/sites for trial execution; manages relationships and ensures quality/performance
- Provides CRO oversight for site start-up/maintenance (trip reports, protocol deviations, data review, etc.)
- Contributes to internal Study Delivery Team (SDT) meetings; supports agenda preparation
- Coordinates preparation, conduct, and presentations at Investigator Meetings
- Assists feasibility assessments and site selection
- Supports protocol development; reviews informed consent forms, case report forms, monitoring plans, and other study materials
- Maintains contact with Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.
- Ensures oversight of regulatory and essential documents; supports development of study plans/documents (VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specs, User Manuals)
- Reviews and oversees study trackers/metrics; oversees development/review of core study documents (Protocol, ICF, CRFs, IRT specs, labels, etc.)
- Identifies/escalates issues; provides risk mitigation strategies
- May mentor and provide training to Sr. Clinical Trial Specialists (CTS)
- May support/own site and vendor invoice reviews
- Travel may be required up to 20%
Supervisory Responsibilities: None
Education/Experience:
- BA/BSN (biological sciences or related) + 7+ years related experience; or MS + 5+; or PhD/PharmD + 0+; or equivalent combination.
- Typically 7+ years life sciences related experience, including 5 years in clinical research.
Knowledge/Skills:
- Experience in study start-up, maintenance, or close-out
- Prospective site-selection criteria development
- Protocol development experience
- Working knowledge and compliance with ICH-GCP, local regulations, SOPs, and study procedures
- Vendor (CRO/lab) interaction experience; oversight of site-proposed ICs for regulatory compliance
- Ability to write/present clearly on scientific/clinical topics; strong organization, communication, interpersonal, and problem-solving skills
- Ability to work in a matrix/team environment and understand technical/medical information