Experienced Study Start Up Coordinator

Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time office-based Regulatory Submissions Coordinator to join our Clinical Operations team in Lyon . This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

Prepare, review, and file clinical trial applications for France;

Prepare and submit responses to queries and amendments to clinical trial applications;

Ensure 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;

Collection of essential documents and preparation essential documents packages for drug release.

Qualifications

A minimum of a Bachelor's degree (preferably in a Life Sciences field);

At least 4-5 years of work experience as a Regulatory Submissions Coordinator;

Hands-on experience preparing, reviewing, and submitting regulatory documentation;

Full professional proficiency in French and English in written and verbal communication;

Knowledge of Microsoft® Office; and

Excellent organization and communication skills, great attention to detail.

Travel: Minimal

We kindly ask to submit applications in English. We would appreciate if you could indicate the status of your work permit if needed.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate