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SoTalent is seeking a Senior Clinical Research Associate (FSP Model) in France, with remote/home-based or office-based options. You will manage full lifecycle site monitoring, ensuring patient recruitment, protocol adherence, and high-quality data within sponsor SOPs and global CRO standards.
The ideal candidate has at least 2 years of independent on-site monitoring in CRO/Pharma, fluent in French and English, and deep knowledge of ICH-GCP.
Professional fluency in both French and English (written and oral) is essential.
A leading global Clinical Research Organization is looking for experienced Clinical Research Associates to join their premier Functional Service Provider (FSP) division.
In this unique role, you will be dedicated to a single pharmaceutical sponsor, allowing you to become a true subject matter expert in their specific molecules and therapeutic pipelines. Unlike traditional multi-sponsor roles, this position offers high continuity, as you will work directly within the sponsor’s SOPs and systems while enjoying the career stability, management, and resource support of a global CRO.
Work-Life Balance: This model utilizes Risk-Based Monitoring (RBM), significantly reducing travel requirements to approximately 30% or less (averaging 6–9 days on-site per month).
Focus: You will typically manage 2–3 protocols and roughly 15 sites, primarily focusing on high-science areas such as Oncology, Immunology, Neurology, or Diabetes.
Flexibility: While the hub is in the Paris region (Gentilly), we welcome applicants from across France, including Bordeaux, Lille, Lyon, Nantes, and Marseille.
Career Growth: Dedicated line management focused on your long-term professional development and consistent workload management.
Full lifecycle site management and monitoring across various regions in France.
Partnering with sites to implement and oversee effective patient recruitment strategies.
Delivering protocol-specific training to site staff.
Generating comprehensive monitoring reports and managing follow-up action plans.
Providing mentorship and co-monitoring support to junior team members where required.
This is a permanent contract offering a highly competitive salary, flexible working arrangements, and the chance to work with some of the most innovative treatments currently in development.