Job Description

If you\xe2\x80\x99ve worn a pair of glasses, we\xe2\x80\x99ve 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 Varilux, Crizal, Stellest), iconic brands that consumers love (such as Ray-Ban, Oakley, Oliver Peoples), as well as a network that offers consumers high-quality vision care and best-in-class shopping experiences (such as Sunglass Hut, LensCrafters, 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.Discover more by following us on LinkedIn!Your #FutureInSight with EssilorLuxotticaAre you willing to pioneer new frontiers, foster inclusivity and collaboration, embrace agility, ignite passion, and make a positive impact on the world? \xe2\x80\x8bJoin us in redefining the boundaries of what\xe2\x80\x99s possible!\xe2\x80\x8bYour roleWe are looking for a Clinical Studies Monitor based in Singapore. You will be responsible to ensure the quality and compliance of clinical research led by Center of Innovation/ R&D Asia team including perform the quality control (monitor) of the study to comply with regulatory requirements.With the deployment of EssilorLuxottica\xe2\x80\x99s healthcare innovation strategy you will be lead a comprehensive and increasing number of clinical studies / investigations of medical devices. You will be a gatekeeper to ensure all clinical studies are in compliant with the complex regulations in different countries in the region, such as Singapore, China, India, etc.Main responsibilities:Perform internal and external studies monitoring (quality control), with or without CRO partnership

• Contribute to site selection for external studies (assessing the center clinical assets)
• Define monitoring plan (write or validate if written by CRO)
• Ensure operational monitoring, being the sponsor - investigator interface, either directly either working with external partners (CROs), in application of monitoring plan (monitoring visits including initiation and close up, oversee of data, checking of investigator site file / trial master file and documents, review events, )
• The activity above is managed independently from the investigation team
• Manage and develop a network of relevant CROs / partners for Asia clinical studies

Contribute to the definition, documentation and communication of the group \xe2\x80\x9cclinical QMS\xe2\x80\x9d

• Document local and global processes through procedures and templates writing and review, in particular about monitoring practice
• Train teams on clinical procedures and more generally in the clinical area (Good clinical practice, privacy\xe2\x80\xa6)
• Ensure a regulatory watch about the evolution of the regulatory environment in the concerned countries

Network of Interaction:Internal: R&D, Medical Professional Affair (MPA), Instruments Science, Quality Regulatory, Legal team.External: local CRO and CRA associations (e.g. Singapore Clinical Research Institute)Main requirements:

• Minimum Bachelor\xe2\x80\x99s Degree in Science and above.
• At least 5years of experience in the industry/ academics/ clinical research organization (CRO) as a Clinical Research Associate/ monitor in Singapore (knowledgeable about local regulations).
• Experience in Medical Device clinical investigations and clinical research.
• Experience in Ophthalmic area and eCRF/EDC software would be a plus.
• Excellent communication skills to liaise with various stakeholders from the region. English is must and Mandarin would be a plus.
• Self-initiator, able to work independently and eye on details.

What\xe2\x80\x99s in it for youIn EssilorLuxottica, you are not defined just by your job title. Each career adventure is unique, but have a glimpse of the benefits and perks you can have by choosing us.

• Gain access to countless opportunities for growth - whether horizontally, vertically, or internationally - within a globally recognized leader that has a strong presence worldwide and covers every step of the value creation process (from R&D to Manufacturing, from Distribution to Stores, and everything in between).
• Join the Employee Shareholding Program to share in the Company\xe2\x80\x99s success and directly benefit from EssilorLuxottica\xe2\x80\x99s growth.
• Possibility of flexible ways of working and entitlement to a set number of paid days off each year to relax, recharge, spend time with family and pursue personal interests.
• Enjoy team-building events and recreational activities organized by our volunteer-based \xe2\x80\x98Happiness Committee\xe2\x80\x99 in Singapore.
• Opportunity to volunteer with the OneSight EssilorLuxottica Foundation and be an active part of our mission to improve lives by improving sight.
• Medical benefits including health insurance coverage for hospital & surgical, outpatient - general practitioner and specialist, TCM, dental, and mental wellbeing.

Recruiting processOur recruitment process may vary; If you are selected, you will be contacted by our recruiters to guide you through the specific steps for your application.\xe2\x80\x8bOur Diversity, Equity and Inclusion commitment\xe2\x80\x8bWe 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.

EssilorLuxottica