Medical Monitor

Job Description Summary

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

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.

Safety Monitoring & Signal Detection

• 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.

Required Qualifications

• MD or equivalent medical degree.
• 3–7 years of experience in clinical trial execution, medical monitoring, or related roles.
• Strong knowledge of GCP, clinical trial conduct, and safety reporting requirements.
• Experience reviewing AEs/SAEs and participating in safety oversight activities.
• Ability to work within protocol and regulatory frameworks while applying sound medical judgment.

Desired Characteristics

• Strong clinical judgment with attention to patient safety and data quality.
• Solid understanding of clinical trial methodology and operational execution.
• Ability to collaborate effectively within cross‑functional and matrixed teams.
• Clear and professional communication with investigators and study stakeholders.
• Detail‑oriented, with strong documentation and compliance mindset.

Additional Information

Relocation Assistance Provided: No