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Clinical Project Manager - Digital Medical Device

Date: 5 juil. 2024

Lieu:

Créteil, FR

We are EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses. The Company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that is uniquely positioned to address the world’s evolving vision needs and the global demand of a growing eyewear industry.

With over 180,000 dedicated employees in 150 countries driving our iconic brands, our people are creative, entrepreneurial and celebrated for their unique perspectives and individuality. Committed to vision, we enable people to “see more and be more” thanks to our innovative designs and lens technologies, exceptional quality and cutting-edge processing methods. Every day we impact the lives of millions by changing the way people see the world.

NCC: F12 evolutive

Digital innovation is now at the heart of EssilorLuxottica’s growth strategy to maintain its leadership position, and the Company is constantly pushing the boundaries of what is possible to understand how to best serve its consumers.

The “Digital Innovation” department develops new digital solutions to support lens innovation and accelerate lens products penetration in all channels. Its mission is to monitor the rapidly changing digital environment, to assess emerging technologies, to partner with the best start-ups and/or universities, to deliver “digital solutions” specific to the optical industry. To achieve this and the support the Group's ambition, the department works closely with its business & marketing divisions to transform these technologies into usable products that meet the specific needs of users and markets.

The developments of digital innovations are iteratively tested from concept phase until implementation in the market. Those tests allow to:

• Orientate decisions regarding technical choices for project teams

• Validate the solutions and write essential reports for regulatory needs and to also support products claims

Most of the tests are clinical investigations adding specificities in the process of development of the solutions.

Within the scope of his/her mission, the Clinical Project Manager will perform the following tasks:

• Define and write in collaboration with the project team the required documents to submit to regulatory authorities and ethics committees,

• Participate in the selection of study sites/investigators, service providers / CROs and other external suppliers in collaboration with the purchase department, the project team and corporate legal department,

• Plan, implement and monitor worldwide clinical investigations (Jardé law in France) on innovative digital medical devices,

• Ensure that projects are compliant with local and international regulations and standards in force,

• Define and writeClinical Evaluation plans and reports,

• Ensure timeline and quality of the specific deliverables linked to clinical investigations,

• Communicate closely with the product project manager,

• Collaborate and align with other departments internally to to analyze, interpret clinical trial data, write reports, present results(Regulatory Affairs, Quality, Legal, Clinical affairs…),

• Ensure a scientific, medical and regultory watch.

We are looking for a candidate with some of the below skills, experience and background:

• Educational Background : High scientific education degree with a medical background,

• Mastery of project management principles and application,

• Understanding of of clinical development with particular emphasis on setup, monitoring and study execution also with subcontractors and CRO,

• Thorough understanding of the international aspects of medical device development process, including strong knowledge of international standards,

• Ideally, an understanding or knowledge of Digital Medical Device as well as ophthalmology or ophthalmic optics (orthoptist/optometrist),

• Previous experience working with Ethical Committee, Health Authorities, Data Protection agency and relevant regulatory and legal knowledge,

• Very good communication skills in French and English,

• Proficiency in Microsoft Office, CTMS, and EDC Systems.

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