RWE Project Manager

Role Overview

• 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

Requirements

• 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.

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.