Start-Up Manager (FSP)
Job Summary
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 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 process improvements and mentoring team members
What were looking for:
- Bachelors degree in Life Sciences Business Finance or related field
- Approximately 5 years of 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 ownership and visibility within country operations
- Minimal travel required
Join Fortrea and play a key role in delivering clinical trials that make a difference!
Learn more about our EEO & Accommodations request here.
Required Experience:
Manager