Experienced Study Start Up Coordinator

Responsibilities

• Prepare, review, and file clinical trial applications for France
• Prepare and submit responses to queries and amendments to clinical trial applications
• Ensure all submissions comply with applicable regulations and guidance documents
• Advise team members on changing regulations and compliance requirements
• Maintain the Clinical Trial Management System and ensure timely filing of documents
• Collect essential documents and prepare essential document packages for drug release

Requirements

• Bachelor's degree, preferably in a Life Sciences field
• 4-5 years of experience as a Regulatory Submissions Coordinator
• Hands-on experience preparing, reviewing, and submitting regulatory documentation
• Full professional proficiency in both French and English (written and verbal)
• Proficiency with Microsoft Office
• Excellent organization, communication skills, and attention to detail

Benefits

• Competitive compensation and benefits package
• Competitive PTO packages
• Flexible work environment
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

About the Company

Medpace is a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. Headquartered in Cincinnati, Ohio, Medpace employs more than 6,000 people across 40+ countries.