Experienced Study Start Up Coordinator
Core
Prepare, review, and file clinical trial applications for France; manage regulatory submissions and document packages for drug release.
Role type
Regulatory Submissions Coordinator
Builds
Clinical trial applications and regulatory documentation for France
Domain
Clinical research / Regulatory affairs
Required skills
Regulatory documentation preparation, Clinical Trial Management System (CTMS) maintenance, French (professional proficiency), English (professional proficiency), Microsoft Office
Preferred skills
Life Sciences degree background, experience in oncology, cardiology, or metabolic areas
Technologies
Clinical Trial Management System, Microsoft Office
Responsibilities
Prepare and submit responses to regulatory queries and amendments; Advise team members on changing regulations; Maintain the Clinical Trial Management System; Collection of essential documents for drug release
Seniority
Mid-level, hands-on IC