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.

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

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