Study Start Up Manager, Poland, IQVIA Biotech
IQVIA · Warsaw, Poland
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Role summary
IQVIA seeks an experienced Study Start-Up Manager to lead site activation, regulatory submissions, and maintenance activities for clinical trials across multiple countries. The position requires overseeing study timelines, budgets, and compliance while collaborating with cross-functional teams. Requires a life sciences degree and 7+ years in clinical research or regulatory affairs, with expertise in GCP guidelines and multi-country trial management.
What they're looking for
- Bachelor's degree in Life Sciences or related field
- Minimum 7 years clinical research, study start-up, or regulatory affairs experience
- International experience in clinical trial environments
- Knowledge of GCP, ICH guidelines, and drug development regulations
- Proven multi-country clinical trial start-up management experience
- CTMS and clinical research systems proficiency
- Leadership, stakeholder management, and cross-functional collaboration skills
What you'll be doing
- Lead global and regional site activation and regulatory activities from start-up through maintenance
- Develop and execute study start-up strategies, project plans, and regulatory submission approaches
- Oversee regulatory submissions, ethics approvals, contracts, and site activation deliverables
- Monitor study progress, quality metrics, timelines, budgets, and resource utilization
- Collaborate with project teams, sponsors, and regional stakeholders to ensure study delivery
Privacy & handoff
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