Medical Monitor

We are seeking an experienced Medical Monitor to support a global Phase III clinical trial in Leber Hereditary Optic Neuropathy (LHON). This is a part-time contract role (0.4 FTE) requiring an experienced physician with a strong background in rare diseases, ophthalmology, and late-phase clinical development.

The Medical Monitor will provide ongoing medical oversight of the study, ensuring subject safety, protocol compliance, data quality, and appropriate medical decision-making throughout trial execution.

Key Responsibilities

• Serve as the primary medical expert for the Phase III LHON clinical study.
• Provide medical oversight and guidance to investigators, CRO partners, and study teams.
• Review and assess adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and safety signals.
• Support medical review of subject eligibility, protocol deviations, and study conduct issues.
• Participate in safety review meetings and data monitoring activities.
• Contribute to review and interpretation of emerging clinical data and study trends.
• Collaborate with Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, and Regulatory teams.
• Support responses to health authority and ethics committee questions related to medical aspects of the study.
• Review clinical documents including protocols, informed consent forms, medical monitoring plans, and clinical study reports.
• Provide input into benefit-risk assessments throughout the study lifecycle.