Job description
Clinical Operations Regional Lead (Clinical Trial Associate)
This is a 6 month contractor position.
Location: South San Francisco or San Diego, hybrid or remote
A leading precision oncology company is seeking a Regional Lead of Clinical Operations to oversee early-phase clinical trials. This role involves managing trial execution from start-up to close-out, ensuring compliance with regulatory standards, and collaborating cross-functionally to drive successful outcomes.
Key Responsibilities:
- Lead regional trial operations, vendor oversight, and site management
- Support study planning, RFPs, and CRO/vendor selection
- Review protocols, ICFs, CRFs, and study plans
- Monitor trial metrics, resolve site issues, and manage risks
- Oversee TMF, CTMS, EDC, IRT systems, and ensure inspection readiness
- Contribute to SOP development and process optimization
- Train site staff and support audits as needed
Qualifications:
- Bachelor’s degree in life sciences or related field
- 6+ years in clinical trial management, preferably in oncology
- Strong knowledge of FDA, ICH/GCP guidelines
- Experience with early-phase and precision medicine trials
- Excellent communication, problem-solving, and organizational skills
- Willingness to travel up to 40%
This is a 6 month contractor position.
Location: South San Francisco or San Diego, hybrid or remote
A leading precision oncology company is seeking a Regional Lead of Clinical Operations to oversee early-phase clinical trials. This role involves managing trial execution from start-up to close-out, ensuring compliance with regulatory standards, and collaborating cross-functionally to drive successful outcomes.
Key Responsibilities:
- Lead regional trial operations, vendor oversight, and site management
- Support study planning, RFPs, and CRO/vendor selection
- Review protocols, ICFs, CRFs, and study plans
- Monitor trial metrics, resolve site issues, and manage risks
- Oversee TMF, CTMS, EDC, IRT systems, and ensure inspection readiness
- Contribute to SOP development and process optimization
- Train site staff and support audits as needed
Qualifications:
- Bachelor’s degree in life sciences or related field
- 6+ years in clinical trial management, preferably in oncology
- Strong knowledge of FDA, ICH/GCP guidelines
- Experience with early-phase and precision medicine trials
- Excellent communication, problem-solving, and organizational skills
- Willingness to travel up to 40%