Medical Monitor

Key Responsibilities

• Provide medical oversight for one or more assigned clinical trials within a program or portfolio.
• Ensure patient safety and protocol-compliant execution throughout trial conduct.
• Apply medical judgment to eligibility questions, protocol deviations, dosing decisions, and participant risk mitigation.
• Review and assess AEs and SAEs, including causality and severity evaluations.
• Participate in ongoing safety reviews, internal safety committees, and Data Safety Monitoring Boards (DSMBs) as required.
• Collaborate closely with Pharmacovigilance to support safety signal detection, escalation, and risk-management actions.
• Support development and implementation of protocol amendments or safety measures when indicated.

Site & Investigator Support

• Serve as a key medical contact for investigators, responding to protocol-specific medical questions and eligibility clarifications.
• Support investigator meetings and site engagement activities with study-specific medical input.
• Provide medical oversight and guidance when studies are conducted with CRO medical monitors, ensuring consistency with GE HealthCare expectations.

Cross-Functional Study Team Collaboration

• Work closely with Clinical Trial Leads (CTLs), Clinical Project Managers (CPMs), CRAs, Data Management, and Biostatistics to support smooth trial execution.
• Participate in operational safety and study management meetings, contributing medical perspective to study-level decisions.
• Support timely identification and resolution of safety or operational risks impacting study conduct.

Regulatory & Documentation Support

• Contribute to clinical study reports (CSRs), safety narratives, and regulatory submission documents.
• Ensure accuracy and consistency of medical data in study documentation and regulatory deliverables.
• Support regulatory interactions by addressing detailed clinical execution and safety questions as required.
• Ensure appropriate SAE reconciliation and alignment between clinical, safety, and regulatory datasets.