Join GE HealthCare as a Medical Monitor, Clinical Development, providing essential day-to-day medical oversight for clinical trials. You will be instrumental in ensuring patient safety, maintaining data integrity, and upholding protocol compliance throughout trial execution. This pivotal role acts as the primary medical liaison for study teams and clinical sites, fostering safe and compliant study conduct in strict adherence to Good Clinical Practice (GCP) and regulatory mandates.

Leveraging defined protocols and robust development strategies, you will apply critical medical judgment during trial execution. This includes evaluating safety signals, assessing participant eligibility, guiding dose modifications, and implementing risk mitigation strategies. Collaboration is key, as you will work closely with Clinical Operations, Pharmacovigilance, Data Management, Biostatistics, and Regulatory Affairs to drive operational excellence, resolve issues promptly, and ensure the delivery of high-quality clinical data.

Key responsibilities include providing medical oversight for assigned clinical trials, ensuring patient safety and protocol adherence. You will apply medical judgment to eligibility, deviations, dosing, and risk mitigation.

Key functions involve reviewing AEs/SAEs, participating in safety reviews and committees, and collaborating with Pharmacovigilance for signal detection and risk management. Support protocol amendments and safety measures as needed.

Serve as a primary medical contact for investigators, responding to protocol-specific queries and eligibility clarifications. Engage in investigator meetings and site activities with study-specific medical input. Provide oversight when studies involve CRO medical monitors.

Collaborate with Clinical Trial Leads, Project Managers, CRAs, Data Management, and Biostatistics for smooth trial execution. Participate in safety and study management meetings, offering medical insights. Facilitate timely identification and resolution of safety or operational risks.

Contribute to clinical study reports, safety narratives, and regulatory submission documents, ensuring accuracy and consistency of medical data. Support regulatory interactions and ensure appropriate SAE reconciliation.

Required qualifications include an MD or equivalent medical degree and 3–7 years of experience in clinical trial execution, medical monitoring, or related fields. A strong understanding of GCP, clinical trial conduct, and safety reporting requirements is essential.

Demonstrated experience in reviewing AEs/SAEs and participating in safety oversight activities is necessary. The ability to operate effectively within protocol and regulatory frameworks while exercising sound medical judgment is crucial.

Desired characteristics include strong clinical judgment with a keen focus on patient safety and data quality. A solid grasp of clinical trial methodology and operational execution is beneficial. The capacity to collaborate effectively within cross-functional and matrixed teams, coupled with clear and professional communication skills, is highly valued. A detail-oriented approach and a strong mindset for documentation and compliance are also important attributes.