Description
We are seeking a Clinical Trial Submissions Coordinator to lead the clinical trial submission process from strategy development through to regulatory approval.
Key Responsibilities:
- Develop and implement submission strategies to ensure timely and successful trial submissions
- Facilitate discussions with cross-functional stakeholders to 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 prior to submission
- Oversee financial planning, budgeting, and tracking activities related to clinical trial submissions
Requirements:
- 3 to 5 years of experience preparing and managing Clinical Trial Regulation (CTR) submissions
- Strong knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable regulatory requirements
- Experience in regulatory affairs and clinical trial submissions
- Proven project management skills, with the ability to coordinate multiple activities and meet deadlines in a fast-paced environment