Clinical Research Director I&I – 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

• Draft clinical documentation including protocols, abbreviated protocols, informed consent forms (ICFs), and amendments
• Provide medical support for real-world data feasibility and operational feasibility assessments.
• Contribute to responses for Health Authorities (HAs), Ethics Committees (ECs), clinical sites, and study teams.
• Participate in and prepare for key meetings (investigator meetings, monitor briefings, etc.).
• Lead and coordinate scientific committees (Steering, DMC, Adjudication): setup, member engagement, charter creation, meeting facilitation, and documentation.
• Support and train cross-functional teams (e.g., CSO PL, GSM, statisticians, CPLs) and external stakeholders (CROs, investigators).
• Provide medical input on study-related documents and processes: study plans (CMP, MRP), CRFs, deviation lists, etc.
• Guide and contribute to data reviews, coding validation, safety surveillance, and clinical case review materials.
• Review patient profiles and validate narratives during Clinical Case Review.
• Review and endorse Statistical Analysis Plans (SAPs).
• Contribute to key results preparation and Clinical Study Report (CSR) writing and review.
• Support audit and inspection readiness and review draft publications.
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