Medical Evidence Project Specialist (MEPS) / Coordinateur IIS at Excelya

Paris, Ile-de-France, France -

Full Time

Start Date

Immediate

Expiry Date

29 May, 26

Salary

0.0

Posted On

28 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Clinical Research Projects, Investigator-Initiated Studies, Pharmacovigilance, Data Integrity, Regulatory Compliance, TMF Coordination, CAPA Monitoring, Statistical Planning, Budget Management, CTMS, Data Management, Communication, Stakeholder Coordination

Industry

Pharmaceutical Manufacturing

Description

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.

Responsibilities

The Medical Evidence Project Specialist will lead and coordinate local project teams for assigned studies, overseeing and supervising CRO activities throughout the entire study lifecycle, including document preparation, committee organization, and TMF coordination. Key duties also involve ensuring full regulatory and internal compliance, guaranteeing data quality, managing pharmacovigilance reconciliation, and overseeing financial aspects of study budgets.