other
Posted 2 weeks agoStart-Up Manager (FSP)
at Fortrea
Warsaw, PolandHybrid
Responsibilities
- Lead country submissions and approvals , working with Ethics Committees and Regulatory Authorities Drive site readiness and ensure delivery of all local start-up milestones Ensure full compliance with ICH/GCP, local regulations, and quality standards Coordinate cross-functional teams (CRA, CTC, Finance, Regulatory, Legal) to deliver country commitments Manage local vendors and oversee supplies, logistics, documentation, and archiving processes Act as a subject matter expert , supporting
Requirements
- experience in clinical research , ideally with exposure to start-up and country operations Strong knowledge of local regulatory environment, submissions, and study start-up processes Excellent organizational, problem-solving, and stakeholder management skills Ability to work independently in a fast-paced, matrix environment Fluency in Polish and English What we offer: Hybrid working model in Warsaw Opportunity to join a growing client-dedicated FSP model with strong global collaboration High level of
Additional details
- Fortrea is expanding its client-dedicated team in Warsaw, Poland (hybrid) and is seeking an experienced Clinical Operations Manager (Start-Up Manager) to lead country-level clinical trial start-up and delivery.
- In this role, you will take ownership of country operations and regulatory submissions , ensuring high-quality execution, compliance, and timely site readiness across assigned clinical trials. Key
- Learn more about our EEO & Accommodations request here .