Medical Monitor – Clinical Development

About the role

The Medical Monitor, Clinical Development provides day‑to‑day medical oversight for one or more clinical trials, ensuring patient safety, data integrity, and protocol compliance. This role serves as the primary medical point of contact for study teams and clinical sites, supporting safe and compliant study conduct in line with Good Clinical Practice (GCP) and regulatory requirements.

Key responsibilities

• Provide medical oversight for assigned clinical trials, ensuring patient safety and protocol‑compliant execution.
• Apply medical judgment to eligibility questions, protocol deviations, dosing decisions, and risk mitigation.
• Review and assess adverse events (AEs) and serious adverse events (SAEs), including causality and severity evaluations.
• Participate in safety reviews, internal safety committees, and Data Safety Monitoring Boards (DSMBs) as required.
• Collaborate with Pharmacovigilance to support safety signal detection, escalation, and risk‑management actions.
• Support development and implementation of protocol amendments or safety measures when indicated.
• Serve as a key medical contact for investigators, responding to protocol‑specific medical questions and eligibility clarifications.
• Provide medical oversight and guidance when studies are conducted with CRO medical monitors.
• Work closely with Clinical Trial Leads, Project Managers, CRAs, Data Management, and Biostatistics to support smooth trial execution.
• Contribute to clinical study reports, safety narratives, and regulatory submission documents.

Required profile

Required skills