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.
Time Commitment
- 0.4 FTE (approximately 2 days per week).
- Flexible scheduling based on study milestones and safety review requirements.
- Participation in periodic study team meetings and safety review meetings expected.
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