Medical Monitor

Job Description SummaryThe 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.

Operating within defined protocols and development strategies, the Medical Monitor provides medical judgment during trial execution, including safety signal evaluation, eligibility assessments, dose modifications, and risk mitigation. The role works closely with Clinical Operations, Pharmacovigilance, Data Management, Biostatistics, and Regulatory Affairs to support operational excellence, timely issue resolution, and high‑quality clinical data.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

The Medical Monitor, Clinical Development is responsible for the daily medical supervision of one or more clinical trials to ensure patient safety, data integrity, and protocol compliance throughout study execution. This position serves as the primary medical point of contact for study teams and clinical sites, ensuring that studies are conducted safely and in compliance with Good Clinical Practice (GCP) as well as regulatory requirements.

Within defined protocols and established development strategies, the Medical Monitor provides medical judgment during trial execution, notably for the evaluation of safety signals, review of participant eligibility, dose adjustments, and risk mitigation measures. The incumbent works in close collaboration with Clinical Operations, Pharmacovigilance, Data Management, Biostatistics, and Regulatory Affairs teams to support operational excellence, rapid problem resolution, and the production of high-quality clinical data.

GE HealthCare is a global leader in medical technologies and innovative digital solutions. Our mission is to create a world where healthcare has no limits. Unleash your ambition, transform your ideas into world-changing realities, and join an organization where every voice matters and every contribution helps build a healthier world.Job Description

• 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.

• 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.

• 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.

• 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.

• Ensure medical oversight of one or more clinical trials assigned within a program or study portfolio.

• Guarantee patient safety and protocol-compliant execution throughout trial conduct.

• Apply medical judgment to eligibility questions, protocol deviations, dosing decisions, and participant risk mitigation measures.

• Review and assess adverse events (AE) and serious adverse events (SAE), including causality and severity analyses.

• Participate in ongoing safety reviews, internal safety committees, and Data Safety Monitoring Boards (DSMB), as required.

• Collaborate closely with Pharmacovigilance to support safety signal detection, escalation, and risk management actions.

• Support the development and implementation of protocol amendments or safety measures when necessary.

• Serve as the primary medical contact for investigators, responding to protocol-specific medical questions and providing clarifications on participant eligibility.

• Contribute to investigator meetings and site engagement activities by providing study-related medical expertise.

• Provide medical oversight and guidance when studies are conducted with CRO medical monitors, to ensure alignment with GE HealthCare expectations.

• Work in close collaboration with Clinical Trial Leads (CTL), Clinical Project Managers (CPM), Clinical Research Associates (CRA), Data Management, and Biostatistics teams to ensure smooth trial execution.

• Participate in operational safety and study management meetings, contributing a medical perspective to decisions made at the study level.

• Support the rapid identification and resolution of safety or operational risks that may affect study conduct.

• Contribute to the writing of Clinical Study Reports (CSR), safety narratives, and documents intended for regulatory submissions.

• Guarantee the accuracy and consistency of medical data in study documentation and regulatory deliverables.

• Participate in interactions with regulatory authorities by responding, if necessary, to detailed questions regarding clinical execution and safety.

• Ensure appropriate SAE reconciliation and data alignment between clinical, safety, and regulatory databases.

• Excellent clinical judgment with a strong sensitivity to patient safety and data quality.

• Good understanding of clinical trial methodologies and their operational execution.

• Ability to collaborate effectively within multidisciplinary and matrixed teams.

• Clear and professional communication with investigators and various study stakeholders.

• Great attention to detail, combined with a strong culture of documentation and compliance.