Medical Evidence Project Specialist (MEPS) / Coordinateur IIS

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 coordinate the local project team for assigned studies

Oversee, coordinate, and supervise CRO activities throughout the entire study lifecycle

Manage preparation and submission of key study documents

Organize and contribute to Steering Committees and Scientific Committees

Ensure Trial Master File (TMF) coordination and documentation oversight

Identify, monitor, and follow up on CAPAs

Perform pharmacovigilance reconciliation activities

Oversee reporting, disclosure activities, and statistical planning

Ensure full regulatory and internal compliance for all managed studies

Guarantee data quality and study integrity

Ensure operational coordination of studies in accordance with regulatory requirements and procedures

Coordinate, when applicable, with the investigational medicinal product coordinator for AAP requests and product management related to IIS

Ensure strict compliance with applicable laws, regulations, and internal policies, including those related to HCP/HCO interactions, promotional rules, Symphony, GSD processes, internal directives, Code of Conduct, and Group standard procedures

Manage study budgets and monitor financial aspects

Experience A proven background in managing clinical research projects, particularly investigator-initiated studies (IIS), preferably within the pharmaceutical or biotech industries.

Skills Strong project management abilities, with proficiency in developing timelines, budgets, and coordinating multiple stakeholders. Experience with clinical trial management systems (CTMS) and data management processes. Excellent communication skills, both verbal and written, and the ability to build and maintain professional relationships.

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.

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.

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