Clinical Research Manager

If you’ve worn a pair of glasses, we’ve already met.

We are a global leader in the design, manufacture, and distribution of ophthalmic lenses, frames, and sunglasses. We offer our industry stakeholders in over 150 countries access to a global platform of high-quality vision care products (such as the Essilor brand, with Varilux, Crizal, Eyezen, Stellest and Transitions), iconic brands that consumers love (such as Ray-Ban, Oakley, Persol, Oliver Peoples, Vogue Eyewear and Costa), as well as a network that offers consumers high-quality vision care and best-in-class shopping experiences (such as Sunglass Hut, LensCrafters, Salmoiraghi & Viganò and the GrandVision network), and leading e-commerce platforms.

Join our global community of over 190,000 dedicated employees around the world in driving the transformation of the eyewear and eyecare industry.

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NCC: G13

Your role:

The Research & Foresight (R&F) department runs the largest number of clinical studies in EssilorLuxottica. A Clinical Research Manager is needed to support R&F research teams in performing clinical studies compliant to regulatory standards, and to interact with the new Head of Clinical Strategy of Group Lens Innovation (GLI).

The primary responsibility of the Clinical Research Manager will be to assist research teams in the execution of both observational clinical studies and clinical trials, particularly during the preparatory and management phases. You will support R&F teams in enhancing their expertise in clinical research management, thereby reducing time delays and improving coordination and alignment with other clinical studies across the organization.

The Research & Foresight’s teams carry out clinical research are in the heart of Paris, next to the Vision Institute and the Quinze-Vingts Ophthalmological National Hospital. You will supervise the regulatory aspects of clinical studies in relation to all the teams present on the site. You will also interact with the Head of Clinical Strategy of our Global Lens Innovation department as well as with all other teams in the group that conduct clinical studies. You will also work with CROs and external clinical investigators. 

Main responsibilities:

·        Clinical research referent for R&F:

o   Oversee all clinical investigations and serve as the primary point of contact regarding clinical studies carried out in R&F

o   Drive a continuous improvement process in the operational coordination of clinical studies

·        During the preparatory phase of clinical studies:

o   Help to define the scope, the organization, and the outcomes

o   Contribute to define interna/external resource needs and means (e.g., study budget plan)

o   Support the writing of clinical protocols, CRFs, and Patient Informed Consent Forms

o   Lead the process of protocol amendments

o   Prepare administrative and regulatory documents for legal submissions (Ethics consent, Health Authorities, Data protection)

·        During the management phase of clinical studies:

o   Monitor internal/external resources associated with deliverables, including visits to meet deadlines, budget and regulations

o   Update the schedule and present the project progress through regular dashboards

o   Ensure high-quality compliance and security with the protocol and procedures in force

o   Handle queries, documentation of deviations, and adverse events

o   Update the Trial Master File in accordance with current regulatory requirements and manage data analysis

o   Prepare and coordinate clinical study reports, ensuring with the regulatory team that they meet legislative and ethical requirements.

o   Administrate clinical trial files

Main requirements: 

At least 10 years of experience in managing clinical research and medical device investigations

An excellent communicator (written and verbal) in French and English, with the ability to prepare well written concise clinical documents is an essential requirement of this position

Analytical, pragmatic, diplomatic, tenacious, and a committed team player. Ability to problem solve, organize, and motivate others

A relevant scientific degree

A depth understanding of EU/FDA/ASIA clinical and regulatory requirements

Interested in making a difference to the health of people

Our Diversity, Equity and Inclusion commitment​

We are committed to creating an inclusive environment for all employees. We celebrate diversity and provide equal opportunities to all, regardless of race, gender, ethnicity, religion, disability, sexual orientation, or any other characteristic that makes us unique.