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Clinical Research Project Leader
Il y a 3 mois
About EssilorLuxottica: We are a global frontrunner in the design, production, and distribution of ophthalmic lenses, frames, and sunglasses. Our company merges the expertise of two industry pioneers—one in advanced lens technologies and the other in the craftsmanship of iconic eyewear—creating a vertically integrated business that is uniquely equipped to meet the evolving vision needs of consumers worldwide.
Our Workforce: With over 180,000 dedicated professionals across 150 countries, our team is known for its creativity, entrepreneurial spirit, and unique perspectives. We are committed to enhancing vision, enabling individuals to "see more and be more" through our innovative designs, exceptional quality, and cutting-edge processing methods. Every day, we make a difference in the lives of millions by transforming how they perceive the world.
Digital Innovation Focus: Digital innovation is central to our growth strategy at EssilorLuxottica. We continuously explore new frontiers to better serve our consumers. The "Digital Innovation" department is responsible for developing new digital solutions that support lens innovation and enhance product penetration across all channels. Our mission involves monitoring the rapidly evolving digital landscape, assessing emerging technologies, and collaborating with leading start-ups and universities to deliver tailored digital solutions for the optical industry.
Role Overview: The Clinical Research Project Leader will oversee the iterative testing of digital innovations from concept to market implementation. These tests are crucial for:
- Guiding technical decisions for project teams.
- Validating solutions and preparing essential reports for regulatory compliance and product claims.
Most tests will involve clinical investigations, adding specific requirements to the development process of these solutions.
Key Responsibilities:
- Collaborate with the project team to define and draft necessary documentation for submission to regulatory authorities and ethics committees.
- Assist in selecting study sites, investigators, service providers, and other external partners in coordination with the purchasing department, project team, and corporate legal department.
- Plan, execute, and monitor global clinical investigations on innovative digital medical devices.
- Ensure compliance with local and international regulations and standards.
- Develop and document Clinical Evaluation plans and reports.
- Maintain timelines and quality for deliverables associated with clinical investigations.
- Foster close communication with the product project manager.
- Collaborate with internal departments to analyze and interpret clinical trial data, write reports, and present findings.
- Conduct scientific, medical, and regulatory monitoring.
Qualifications:
- Advanced scientific education with a medical background.
- Strong project management skills and application knowledge.
- Understanding of clinical development, particularly in setup, monitoring, and execution with subcontractors and CROs.
- Comprehensive knowledge of the international medical device development process and standards.
- Familiarity with Digital Medical Devices and knowledge of ophthalmology or ophthalmic optics is preferred.
- Experience working with Ethical Committees, Health Authorities, and relevant regulatory bodies.
- Excellent communication skills in both French and English.
- Proficiency in Microsoft Office, CTMS, and EDC Systems.
