Clinical Trial Submission Coordinator (Clinical Research) - Sponsor dedicated - Poland

Location: Warsaw, Poland

Salary: PLN 105,900–374,100 annualized

Company

IQVIA provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Lead clinical trial submission processes from strategy development through regulatory approval.
• Develop, plan, and coordinate submission strategies to support timely trial submissions.
• Facilitate cross-functional discussions, consolidate stakeholder input, and drive alignment on CTR submission strategies.
• Coordinate 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 for clinical trial submissions.

Requirements

• 3–5 years of experience preparing and managing Clinical Trial Regulation (CTR) submissions.
• Experience in regulatory affairs and clinical trial submissions.
• Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
• Proven project management skills, including coordinating multiple activities and meeting deadlines in a fast-paced environment.

Culture & Benefits

• Full-time employment.
• Health and welfare benefits may be provided.
• Additional incentive plans, bonuses, or other compensation may depend on the position offered.