Key Responsibilities

Clinical Trial Medical Oversight

• 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.

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