Manager, REMS and Clinical Operations
$116,000–$151,000 year
On-site · San Diego, California, United States
Job Summary
Manager, REMS & Clinical Operations responsible for leading REMS program management and supporting select Phase 1–3 clinical operations activities. Role includes overseeing REMS program timelines, deliverables, documentation, metrics and audit/inspection readiness, while coordinating vendor activities and cross-functional teams. Also contributes to study execution through vendor oversight, protocol/tool development, site materials, budget tracking, and ensuring compliance with GCP and regulatory requirements. Requires strong project/program management, vendor management, and communication skills; travel up to 10–20% domestically and internationally. Bachelor's degree and 6+ years in pharma/CRO environment with REMS or risk-management experience; pharmacovigilance/clinical operations knowledge preferred.
Required Qualifications
- Bachelor’s degree or equivalent combination of education and applicable job experience
- 6+ years of experience in pharmaceutical, biotechnology, or CRO industry
- 3-5+ years of direct experience supporting REMS or similar risk management programs preferred
- Experience in clinical trial operations (Phase 1–3) required or strongly preferred
- Working knowledge of FDA regulations, global clinical regulations and REMS requirements, as well as ICH/GCP guidelines
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.