Clinical Project Manager

il y a 5 jours


Créteil, Île-de-France EssilorLuxottica Temps plein
About the Role

We are seeking a highly skilled Clinical Project Manager to join our Digital Innovation department at EssilorLuxottica. As a Clinical Project Manager, you will play a critical role in the development and implementation of digital medical devices, working closely with cross-functional teams to ensure compliance with regulatory requirements and standards.

Key Responsibilities
  • Regulatory Compliance: Ensure that projects are compliant with local and international regulations and standards, including the Jardé law in France.
  • Clinical Investigation Planning: Plan, implement, and monitor worldwide clinical investigations on innovative digital medical devices.
  • Document Management: Define and write required documents to submit to regulatory authorities and ethics committees, including clinical evaluation plans and reports.
  • Project Management: Ensure timeline and quality of specific deliverables linked to clinical investigations, collaborating closely with the product project manager and other departments.
  • Communication: Communicate closely with the product project manager, regulatory affairs, quality, legal, and clinical affairs teams to analyze, interpret clinical trial data, write reports, and present results.
Requirements
  • Education: High scientific education degree with a medical background.
  • Project Management: Mastery of project management principles and application.
  • Clinical Development: Understanding of clinical development with particular emphasis on setup, monitoring, and study execution, including subcontractors and CROs.
  • Regulatory Knowledge: Thorough understanding of the international aspects of medical device development process, including strong knowledge of international standards.
  • Digital Medical Device: Ideally, an understanding or knowledge of digital medical devices, as well as ophthalmology or ophthalmic optics (orthoptist/optometrist).
  • Communication Skills: Very good communication skills in French and English.
  • Technical Skills: Proficiency in Microsoft Office, CTMS, and EDC Systems.

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