Clinical Trials Manager

Responsibilities:
- Coordinate and supervise all aspects of clinical studies; monitor clinical trial sites.
- Assist Clinical Program Manager in overall study management.
- Draft and coordinate review of study documents (protocols, informed consents, case report forms, monitoring plans, investigator brochures, clinical study reports).
- Maintain study timelines.
- Contribute to study budget development; develop RFPs and help select CROs/vendors.
- Manage CROs/vendors; coordinate review of data listings and preparation of interim/final clinical study reports.
- May contribute to abstracts, presentations, and manuscripts; ensure effectiveness of site budget/contract process.
- May train CROs, vendors, investigators, and study coordinators on study requirements.
- Under supervision, may design scientific communications.
- Travel is required.

Basic Qualifications:
- Bachelor’s + 5 years’ experience OR Master’s + 3 years’ experience.

Preferred Qualifications:
- 6+ years’ experience and an RN (2 or 3 year certificate).

Required/Desired Skills:
- Excellent teamwork, communication, decision-making, and organizational skills.
- Desirable: thorough knowledge of FDA and/or EMEA regulations, ICH guidelines, and GCP.
- Ability to interpret/explain protocol requirements; prioritize multiple tasks; participate in strategic initiatives; support SOP development/implementation.

Salary (base range):
- Other US Locations: $133,195–$172,370; Bay Area: $146,540–$189,640.

Application Instructions:
- For current employees and contractors: apply via the Internal Career Opportunities portal in Workday.