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International RWE project manager
il y a 2 semaines
HybridOperations, Clinical Ops & eTMFFull time
Paris, Île-de-France, France
OVERVIEW
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.
As an external Global Evidence Generation manager, you will be responsible for the international management of several clinical studies (prospective Phase IV and / or epidemiological or retrospective studies) including Real World Evidence studies. You will contribute to the design of new projects defined portfolio strategy as well as the impactful communication of key results. The role requires a strong background in international and local study management, including the management of global Clinical Research Organizations, central medical review, statistical interpretation.
Main Responsibilities:
Lead and oversee complex international clinical projects, ensuring high-quality execution across all phases.
Manage global CROs (including Data Management, Biometry) and coordinate both global and local stakeholders.
Drive the preparation, review, and validation of core study documentation (protocols, ICFs, SAPs, CSR review).
Oversee data quality through central medical review, query management, and interpretation of statistical outputs.
Support scientific dissemination by reviewing abstracts, posters, and manuscripts.
Ensure efficient communication and alignment through project slide decks, newsletters, and results cascade.
Select and manage subcontractors and provide strong operational support to affiliates worldwide.
Supervise Trial Master File compliance and contribute to local study management from start-up to closure.
Collaborate effectively with internal teams and external partners to secure project success.
Knowledge in Hypertension and Dyslipidemia and/or in Cardiology & Diabetes is a plus.
Requirements
About you
We are looking for a candidate who embodies our values of Audacity, Care, and Energy, and who brings a strong scientific and managerial background to the role.
Education: Master's degree in Biology or a related Life Sciences field.
Experience: Proven experience in international and local clinical study management within clinical operations, A previous experience in RWE, preferably within medical affairs is a plus.
Technical skills: Strong knowledge of Ethical and regulatory requirements for clinical studies, Strong knowledge of compliance, Ability to work effectively across global and local teams, Excellent organizational and project management skills
Languages: Fluent in English & French.
Benefits
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.
