Clinical Trial Submission Coordinator - Sponsor dedicated - Poland
IQVIA · Warsaw, Poland
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Role summary
This role manages the operational and strategic aspects of clinical trial submissions in Poland, guiding projects from strategy development through regulatory approval. Key responsibilities include coordinating submission processes via CTIS portal, conducting quality control reviews, facilitating cross-functional alignment, and overseeing financial planning. The position requires 3–5 years of CTR submission experience, solid knowledge of GCP and ICH guidelines, and strong project management capabilities.
What they're looking for
- 3-5 years preparing and managing Clinical Trial Regulation submissions
- Knowledge of Good Clinical Practice, ICH guidelines, and regulatory requirements
- Experience in regulatory affairs and clinical trial submissions
- Project management skills with ability to coordinate multiple activities and meet deadlines
What you'll be doing
- Lead clinical trial submission process from strategy development through regulatory approval
- Develop and coordinate submission strategies for timely and successful trial submissions
- Facilitate cross-functional stakeholder discussions and drive alignment on submission strategies
- Coordinate and manage submissions through the Clinical Trials Information System portal
- Perform quality control reviews of CTIS applications and submission packages
Privacy & handoff
This role links to IQVIA's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.