Permanent (‘CDI’) – Lille, France – Hybrid
ABOUT OUR CLIENT
Our client is the French R&D division of a Swiss clinical-stage pharmaceutical company dedicated to identifying, developing, and commercializing novel antibacterial products for serious, life-threatening infections caused by multi-drug resistant (MDR) bacteria.
The company is currently advancing a Phase 2 program in collaboration with esteemed partners such as the University of Lille and GlaxoSmithKline (GSK).
THE OPPORTUNITY
As part of a small, dynamic team based in Lille, France, the Clinical Trial Manager will play a pivotal role by managing clinical trials from initiation to completion.
Reporting to the Chief Development Officer, and working closely with internal teams and external partners, you will:
- Oversee and manage all aspects of clinical trials, ensuring timelines, quality, and budget targets are met.
- Develop and review study protocols, ICFs, and clinical study reports.
- Supervise CRO activities, including site monitoring and study supply forecasting.
- Ensure compliance with GCP, internal SOPs, and regulatory requirements.
- Manage regulatory submissions and maintain the TMF.
- Select, manage, and evaluate external service providers.
- Coordinate pre-audit activities and CAPA resolutions.
YOUR PROFILE
- Master’s degree in Life Sciences or Healthcare.
- Minimum 4 years’ experience in clinical development and trial management.
- Strong project management skills.
- You have the autonomy, flexibility, and adaptability required to thrive in a dynamic biotech environment.
- You are a real team player with a friendly, positive attitude.
- You are comfortable taking on tasks beyond the initial scope and contributing to cross-functional projects.
- Fluent in English.
- French would be an advantage. Other languages would be a plus.
- Experience with antibiotic therapies would be a plus.
- Previous CRA/monitoring experience is a plus.
BENEFITS
- Attractive remuneration package.
- Opportunity to work in a cutting-edge biotech environment.
- Premises located within the Institut Pasteur, in the centre of Lille, close to all transport links.
- Remote work up to 2 days a week.
Alternatively, 1 week remote work per month would be considered. - 10 additional paid leave days (‘jours de RTT’) on top of the statutory 25 days of annual leave.
- ‘Statut cadre’ Executive-level employment status with associated benefits.
- Occasional travel (4-5 times/year).
Ref : PR-0279