Salary: $160 - $200K
Location: South San Francisco, CA (Hybrid - must be local)
Company Summary: Working with the C-suite of a precision IO biotechnology company to build out their clinical operations team in an effort to develop best-in-class immunotherapies to address unmet needs within the oncology space. Their pipeline consists of 1 Phase Ib asset and 4 more preclinical assets. They are looking for a Sr. Clinical Trial Manager to join the team on a full-time basis.
Responsibilities:
- Managing all clinical operational aspects of a global clinical trial including start-up, conduct and close out activities.
- Identifying potential study issues/risks and recommends/implements solutions.
- Managing CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project files) and serves as the primary CRO/vendor contact.
- Contributing to the writing, review and finalization of protocols or components of clinical study reports.
- Organizing clinical operational meetings.
- Developing and maintaining strong working relationships with principal investigators, key clinical opinion leaders and sites.
- May be responsible for contributing to development of RFPs and participates in selection of CROs/vendors as well as review of any CRO budgets and /or change orders.
- Developing strong cross-functional relationships and exhibits leadership skills with counterparts to ensure efficient execution of clinical trial.
- Ensuring adherence with SOP, applicable regulations, GCP, and ICH guidelines.
- Contributes to the development and/or review of study plans, ICFs, site manuals, patient materials, CRF completion guidelines, etc.
- Attend and/or present at Investigator Meetings as needed.
Requirements:
- At least 8 years of industry (must be at a sponsor) experience REQUIRED
- 5-8 years of oncology trial management experience
- Global trial experience preferred
- A Bachelor's degree in Biological Sciences, Nursing, Pharmacy or a related discipline
- A working knowledge of ICH GCP guidelines
Benefits:
- Pre-IPO biotech company
- Competitive salary with comprehensive benefits (90% medical coverage)
- Flexible PTO and WFH arrangements
- 401K contribution
- Cell phone reimbursement, life insurance, and additional perks
