As Clinical Project Manager, you will be responsible for the following activities:   

Clinical evaluation of pre-market products:  

• Manage the implementation and follow-up of pre-market clinical investigations in compliance with regulations applicable in the various countries participating in the investigation  

• Conduct medical literature reviews   

• Contribute to the organization of cadaver labs 

  Clinical evaluation of Post-Market products (once the product is released on the market): 

• Manage the implementation of one or more post-market clinical studies  

• Participate in the post-market follow-up of DM (implementation of questionnaires, etc.)  

• Participate in the management of adverse events and material vigilance cases. 

• Participate in the post-market follow-up of the medical device (implementation of questionnaires, etc.)   

As part of his or her missions, the Clinical Project Manager will be required to:   

• Coordinate external service providers (CRO, medical writer, etc.) and internal resources to ensure the smooth running of clinical studies preparation and implementation (including provision of robots, consumables, user training, etc.).   

• Build budget and plan - follow expenses and project progress 

• Discuss with clients (healthcare professionals, hospital pharmacies, etc.) and participate in contractual negociations 

• He or she will also provide scientific support for the drafting of marketing brochures.   

• In addition, he or she must be an actor in the Quality Management System in place within the company and participate, through his or her actions, in the continuous improvement of the company’s products.

• Engineering diploma or equivalent in Life Sciences   

• Minimum 5 years of experience in medical device industry, as clinical studies specialist  

• Knowledge of the regulatory environment : ISO 14155 :2020, MDR 2017/745, MEDDEV 2.7.1…  

• Successful experience in project management  

• Operating room knowledge  

• Strong writing skills  

• Fluent in English 

• Excellent interpersonal skills 

• Strong problem-solving, analysis and synthesis skills.  

• Good communication skills and ability to work independently within a highly-motivated team environment.  

• “Attaché de recherche Clinique” qualification is a plus 

• Prior experience in orthopedics is a plus