Clinical Affairs Program Manager France

Clinical Affairs Program Manager France, France

This role is for a global medical device company specializing in MR-guided focused ultrasound technology. The position is remote with up to 40% travel within Europe.

Responsibilities

• Collaborate with stakeholders to execute clinical trial objectives, including investigator-sponsored studies.
• Design clinical trials, develop protocols, and manage discussions with EU authorities.
• Manage the selection, contracting, and oversight of investigators, sites, and vendors.
• Obtain necessary approvals from IRBs/ECs and ensure timely study initiation and patient recruitment.
• Develop budgets and ensure financial targets are met.
• Interpret and document clinical results for regulatory submissions and publications.
• Build and maintain collaborations with investigators, researchers, and key opinion leaders.
• Develop SOPs and ensure compliance with GCP, FDA, ISO, and other guidelines.
• Identify training needs and develop appropriate training materials.

Required Skills and Experience

• BSc, BA, BSN, RN, or higher in Life Sciences or related fields.
• At least 3 years in a clinical management role within the biopharmaceutical or medical device industry or CRO.
• Minimum of 4 years direct experience managing clinical trials, especially Phases I-III.
• Strong knowledge of GCP, ICH, ISO guidelines; FDA or Health Canada experience is a plus.
• Experience managing labs, data management, biostatistics, and safety reporting.
• Proficiency with electronic data capture and clinical trial management systems.
• Excellent communication, organizational, and program management skills.
• Fluent in English; additional languages are advantageous.
• Willing to travel domestically and internationally up to 40%.