Project Specialist RWE

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.

Working in close collaboration with the Therapeutic Area Medical Lead, the Data Generation Strategy Lead, the Medical Data Center Statistician, Pharmacovigilance teams, and partners, the MEPS will manage assigned studies across one or more therapeutic areas, including Oncology, Hematology, Neuroscience, Immunology, and Ophthalmology.

The role requires strict adherence to applicable regulations, internal procedures, and compliance standards, ensuring high-quality study execution and data integrity.

Main responsibilities :

• Lead and manage the local project team, and oversee / coordinate / supervise the CRO for all study‑related activities, including: development and submission of key study documents, scientific committee management, TMF coordination, CAPA identification and follow‑up, PV reconciliation, reporting & disclosure, activity planning for statistics, etc.
• Ensure compliance for the studies under the responsibility of the service provider’s Medical Evidence
• Ensure data quality throughout all study activities.
• Provide operational coordination of the studies managed in compliance with regulatory requirements and client procedures.
• Coordinate with the investigational medicinal product (IMP) coordinator for managing AAP requests (if applicable) and investigational product supply for IIS (if applicable).
• Comply with all applicable laws, regulations, and compliance rules, particularly those related to interactions with HCPs/HCOs, Symphony, GSD, promotional rules, directives, the code of conduct, and internal policies and standard procedures.

Requirements:
Experience: Experience in management of Compassionate Use Prescription (CPC)

Skills: Knowledge of a medicinal product development plan and strong/mandatory knowledge of study management, with experience in vendor management, proven ability to manage cross‑functional teams and demonstrate high adaptability.

Education: Bachelor’s degree in Life Sciences, Pharmacy, or related field. Advanced degrees (Master’s or PhD) are a plus.

Languages: Fluency in French and English is required.

Benefits:
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.