Clinical Trial Submission Coordinator (Sponsor Dedicated)

About the role

iQVIA is looking for a Clinical Trial Submission Coordinator in Prague, working on sponsor-dedicated projects. The role covers the operational and strategic coordination of clinical trial submissions, from strategy development through to regulatory approval.

Key responsibilities

• Lead the clinical trial submission process from strategy development through to regulatory approval.
• Develop, plan and coordinate submission strategies to ensure timely and successful trial submissions.
• Facilitate discussions with cross-functional stakeholders, consolidate input and drive alignment on CTR submission strategies.
• Coordinate and manage submissions through the Clinical Trials Information System (CTIS) portal.
• Perform quality control reviews of CTIS applications and submission packages before submission.
• Oversee financial planning, budgeting and tracking activities related to clinical trial submissions.

Required profile

• 3 to 5 years of experience preparing and managing Clinical Trial Regulation (CTR) submissions.
• Experience in regulatory affairs and clinical trial submissions.
• Proven project management skills, able to coordinate multiple activities and meet deadlines in a fast-paced environment.

Required skills

• Strong knowledge of Good Clinical Practice (GCP) and ICH guidelines, and applicable regulatory requirements, applied effectively in a clinical research environment.
• Use of the CTIS portal for managing submissions.