Senior Manager, Clinical Operations
$132,000–$172,000 year
HybridSan Diego, California, United States
Job Summary
Manage and provide daily oversight of internal study teams, full-service CROs, clinical sites, and third-party vendors to ensure successful Phase 1 through 3 clinical trial implementation. Triage, resolve, or escalate study issues to Clinical Operations Management while evaluating unpredictable scenarios to achieve project timelines. Guide functional activities including Biometrics and PV to ensure compliance with study plans, SOPs, and ICH/GCP regulations. Track study status, enrollment, regulatory documentation, and site start-up progress, and independently lead cross-functional activities to meet study management goals. Oversee CRO/vendor budgets and manage trial-related materials and laboratory samples. Requires 7+ years of clinical trial experience with 2+ years managing studies at a sponsor or CRO, plus ability to travel 10-20% domestically and internationally.
Required Qualifications
- Bachelor's degree or equivalent combination of education and applicable job experience
- 7+ years of clinical trial experience
- 2+ years of experience managing clinical studies at a sponsor or CRO
- Experience in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH E6 (R2) GCP
- Ability to travel 10-20% domestically and internationally
- Ability to perform face to face work with colleagues and/or onsite in San Diego
Desired Qualifications
- Phase 1 -3 study experience or relevant experience including international studies
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.