Clinical Research Manager
il y a 4 jours
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.
Your #FutureInSight with EssilorLuxottica
Are you willing to pioneer new frontiers, foster inclusivity and collaboration, embrace agility, ignite passion, and make a positive impact on the world? Join us in redefining the boundaries of what's possible
A Clinical Research Manager is needed to support Essilor research teams in performing clinical studies compliant to regulatory standards and to interact with the new Head of Clinical Strategy.
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,management and close-out phases. We expect him/her to support Essilor teams by enhancing their expertise in clinical research management, thereby reducing time delays and improving coordination and alignment with other clinical studies across the organization.
Responsabilities
During the preparatory phase of clinical studies:
- Help to define the scope, organization, budget, timelines, and outcomes
- Contribute to define internal/external resource needs and means
- Oversees CRO activities (e.g. regulatory submission, monitoring activities, SAE reporting) Assists in contracting and negotiating budgets with clinical sites or universities
- Support the writing of clinical protocols, CRFs, and Patient Informed Consent Forms, investigation risk analysis
- Prepare administrative and regulatory documents for legal submissions (Ethics consent, Health Authorities, Data protection)
During the management phase of clinical studies:
- Monitor internal/external resources associated with deliverables, including visits to meet deadlines, budget and regulations
- Update the schedule and present the project progress through regular dashboards
- Ensure high-quality compliance and security with the protocol and procedures in force
- Lead the process of protocol amendments
- Handle queries, documentation of deviations, and adverse events
- Update the Trial Master File in accordance with current regulatory requirements
- Manage data analysis
- Prepare and coordinate clinical study reports, ensuring with the regulatory team that they meet legislative and ethical requirements.
Candidate profile:
- At least 5-10 years' experience in clinical research managing position, preferably in the medical device industry.
- 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
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