Medical Monitor - Contract Role - 12 months

At CooperVision, a division of CooperCompanies, we're driven by a unifying purpose to help people to experience life's beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges - including astigmatism, presbyopia, and childhood myopia. We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at www.coopervision.com .

Temp contractor:

12 months

Location:

San Ramon Job Summary:

Ensure the safety and integrity of clinical trials and global regulatory safety compliance.

Knowledge, Skills and Abilities:

Experience with safety reporting and/or Health Hazard Evaluations Understand standardized medical coding, GCP, ISO and regulatory reporting requirements Ability to manage multiple projects and adjust to changing priorities Excellent communication skills, both verbal and written, including appropriate use of medical and scientific terminology Optometry or ophthalmology background/training

Work Environment:

Normal office environment Limited travel (no more than 10%)

Experience/Education:

OD or MD ophthalmologist with active US license (OD in California) Ideally 5 years of experience with pharmacovigilance, regulatory affairs, medical monitoring, or similar clinical trial experience Experience in contact lens or medical device industry strongly preferred

Essential Functions & Accountabilities:

Serve as Medical Monitor for pre-market and post-market clinical trial activities to ensure safety compliance with protocols, ICH-GCP, and regulatory requirements (e.g.

FDA, EU-MDR, ISO

etc.). Review adverse event (AE) submissions for completeness, clarity, and appropriateness of severity and relatedness classification in a timely fashion to ensure compliance with reporting timelines. Serve as the primary medical contact for internal and external investigators and supporting personnel. Report Serious Adverse Events (SAEs) and Unanticipated Serious Adverse Device Effects (USADEs) to Quality Affairs (QA) and the relevant notified bodies, as required, and within required timeframes. Perform monthly review of pre-market AEs with QA. Generate monthly KPI reports for distribution to RA and Quality Assurance (QA) functions for pre-market studies. Work with RA and QA to review global complaints, AEs and failure rates Act as licensed doctor for AE oversite in San Ramon Internal Clinic trials Serve as SME for protocol, investigator brochure, study reports, etc. relative to safety endpoints. Provide safety input into Product Hazard assessments and evaluations Support R D QA during audits for inquiries relating to AE and Product Complaint reporting. Participate in or facilitate Data Safety Monitoring Board (DSMB) reviews Develop and oversee delivery of safety training materials Collaborate with RA on review and assessment of documents of external origin (DOEO) and relevance to ongoing clinical activities