Global Clinical Operations Lead Rare Disease – France

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here’s what makes us unique

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

• Supervise the Clinical team of CROs to ensure an efficient study start-up.
• Monitor the collection and submission of essential regulatory and ethics documents.
• Ensure CRO completion of EDC tasks within defined timelines.
• Train CRAs on study-specific activities and organize investigator/monitor meetings.
• Establish detailed project milestones in collaboration with the study team.
• Draft and validate key clinical oversight documents (manuals, monitoring plans, etc.).
• Review and follow up on site visit reports to address identified issues.
• Coordinate and manage the CRO relationship while supporting internal CRAs when needed.
• Perform co-monitoring visits to ensure study quality and resolve site-related issues.
• Track and report study data (CTMS), review TMF, and assist in audit preparation.