Medical Monitor

As a Medical Monitor within the clients R&D Clinicals team, you will work with 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.), while serving as the primary medical contact for internal and external investigators.

As a Medical Monitor, you will be responsible for ensuring safety compliance and serving as the primary medical contact for clinical trial activities.

• 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 Regulatory Affairs (RA) and the relevant notified bodies, as required, and within required time frames.
• Perform monthly review of pre-market AEs with RA.
• 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.
• 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.

• MD ophthalmologist with active license.

• 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.

• Ideally 7-10 years of experience with pharmacovigilance, regulatory affairs or medical monitoring.
• Experience in contact lens or medical device industry preferred.