Lead the planning and execution of European Union Clinical Trials Regulation Part II submissions throughout the study lifecycle.
Responsibilities
Lead the planning and execution of EU Clinical Trials Regulation Part II submissions
Partner with Clinical Trial Management and Regulatory Affairs to define country allocation, submission strategy, breakthroughs, and timelines
Coordinate Member State, institution, principal investigator, and site-level information and documentation required for clinical trial applications
Prepare and maintain accurate submission content in the Clinical Trials Information System and ensure alignment with national requirements
Collaborate with Clinical Transparency on document redactions and collect compliant documentation for In Vitro Diagnostic Regulation ethics submissions