Clinical Research Project Leader
il y a 4 semaines
About Us: We are EssilorLuxottica, a worldwide frontrunner in the design, production, and distribution of optical lenses, frames, and sunglasses. Our company unites the complementary skills of two industry innovators, one specializing in advanced lens technologies and the other in the craftsmanship of iconic eyewear, creating a vertically integrated enterprise that is uniquely equipped to meet the evolving vision needs of the world and the increasing demand in the eyewear sector.
Our Workforce: With a dedicated team of over 180,000 employees across 150 countries, we drive our renowned brands forward. Our personnel are known for their creativity, entrepreneurial spirit, and celebrated for their unique perspectives and individuality. Committed to enhancing vision, we empower individuals to "see more and be more" through our innovative designs, superior quality, and cutting-edge processing techniques. Each day, we transform the lives of millions by changing how they perceive the world.
Digital Innovation: At the core of EssilorLuxottica's growth strategy lies digital innovation, which is essential for maintaining our leadership position. The company continually explores the limits of what is achievable to better serve our consumers.
Department Overview: The "Digital Innovation" department is responsible for developing new digital solutions that support lens innovation and expedite the penetration of lens products across all channels. Its mission involves monitoring the rapidly evolving digital landscape, evaluating emerging technologies, and collaborating with top start-ups and universities to deliver tailored "digital solutions" for the optical industry. To support the Group's ambitions, the department works closely with business and marketing divisions to convert these technologies into practical products that cater to the specific needs of users and markets.
Clinical Investigations: The development of digital innovations undergoes iterative testing from the concept phase to market implementation. These tests facilitate:
- Guiding decisions regarding technical choices for project teams.
- Validating solutions and preparing essential reports for regulatory compliance and product claims.
Most tests are clinical investigations, adding specificities to the development process of the solutions.
Role Responsibilities: As a Clinical Research Project Leader, you will be tasked with:
- Collaborating with the project team to define and draft necessary documents for submission to regulatory authorities and ethics committees.
- Assisting in the selection of study sites, investigators, service providers, CROs, and other external suppliers in partnership with the purchasing department, project team, and corporate legal department.
- Planning, executing, and monitoring global clinical investigations on innovative digital medical devices.
- Ensuring compliance with local and international regulations and standards.
- Defining and drafting Clinical Evaluation plans and reports.
- Overseeing timelines and quality of deliverables related to clinical investigations.
- Maintaining close communication with the product project manager.
- Collaborating with various internal departments to analyze and interpret clinical trial data, prepare reports, and present results.
- Ensuring ongoing scientific, medical, and regulatory monitoring.
Candidate Profile: We seek candidates with the following qualifications:
- Advanced scientific education with a medical background.
- Proficiency in project management principles and their application.
- Understanding of clinical development, particularly in setup, monitoring, and study execution with subcontractors and CROs.
- Comprehensive knowledge of the international medical device development process, including familiarity with international standards.
- Ideally, knowledge of Digital Medical Devices and experience in ophthalmology or ophthalmic optics.
- Previous experience working with Ethical Committees, Health Authorities, and relevant regulatory and legal frameworks.
- Excellent communication skills in both French and English.
- Proficiency in Microsoft Office, CTMS, and EDC Systems.
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