Key Responsibilities 

1. Clinical operation management  

   • Develop and manage detailed project plans, including timelines, budgets, and resource allocation.

   • Coordinate and oversee all stages of clinical trials, from planning and initiation to execution and closeout.

   • Ensure all project milestones and deliverables are met on time and within budget.

   • Maintain comprehensive and accurate project documentation, including study protocols, informed consent forms, and case report forms.

   • Prepare and present regular progress reports to senior management.

   • Ensure proper documentation and archiving of all trial-related materials.

   • Monitor clinical investigations centers

2. Regulatory Compliance 

   • Ensure all clinical trials comply with local and international regulatory requirements, including GCP guidelines.

   • Prepare and submit regulatory documents to appropriate authorities (ANSM, GMED and ethic committees).

   • Monitor and report on compliance issues and implement corrective actions as necessary.

Professional profile required  

1. Education

• Master’s degree or PhD in engineering, life science, bioengineering or similar

1. Experience 

• Minimum of 4 years of relevant experience in clinical research in a CRO or medical device or pharmaceutical industry 

• Has a prior experience as a clinical project manager or a similar role including extensive experience managing clinical studies from planning to completion 

3) Technical Skills: 

• Experience with EDC systems for electronic data entry and management. 

• Ability to design and manage electronic case report forms (eCRFs) in collaboration with the data manager. 

• Proficiency in English and French (both written and spoken).

4) Soft Skills: 

• Strong project management and organizational skills. 

• Excellent attention to detail and organizational abilities. 

• Effective communication and teamwork skills.

1. HR Screen call (15min)

2. Interview with Giulia FAEDDA, Head of Clinical (1h)

3. Interview with Caroline Florequin, Head of Regulatory and Compliance (45min)