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Clinical Trial Submission Coordinator - Sponsor dedicated - Czech Republic

IQVIA · Prague, Czechia

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Clinical OperationsFull-timeCompany career page

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Role summary

IQVIA seeks a Clinical Trial Submission Coordinator to manage the end-to-end submission process for clinical trials, from strategy development through regulatory approval. The role involves coordinating cross-functional activities, managing submissions via CTIS portal, and overseeing associated financial planning.

What they're looking for

  • 3-5 years of experience preparing and managing Clinical Trial Regulation submissions
  • Strong knowledge of GCP, ICH guidelines, and applicable regulatory requirements
  • Background in regulatory affairs and clinical trial submissions
  • Proven project management skills with ability to coordinate multiple activities

What you'll be doing

  • Lead clinical trial submission process from strategy development through regulatory approval
  • Develop and coordinate submission strategies to ensure timely and successful approvals
  • Facilitate cross-functional stakeholder discussions and drive alignment on submission strategies
  • Coordinate submissions through CTIS portal and perform quality control reviews
  • Oversee financial planning, budgeting, and tracking for clinical trial submissions

Privacy & handoff

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RoleLantern checkedNeeds clarity
Date posted22 days ago
Last source check1 day ago
Salary listedNeeds clarity
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