Medical Monitor Contract Role 12 months

At CooperVision a division of CooperCompanies were driven by a unifying purpose to help people to experience lifes 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 .

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