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Expect scenarios on SAE triage, protocol deviation judgment, and how you set medical-monitoring quality bars across programs. Be ready to describe directing other monitors, working with CROs/sponsors, and communicating safety risk to non-medical stakeholders—without relying on unpublished compensation or review sites.
Best fit is an experienced clinical/medical monitoring leader comfortable on-site in Morris County who can own safety judgment at director level for System One’s client or program work. Data here does not support culture scores, pay bands, or named certifications.
As Director Medical Monitor at System One in Parsippany, the day is leadership of clinical safety oversight: reviewing adverse events and protocol safety questions, aligning medical monitoring standards with study teams and sponsors, coaching medical monitors, and escalating risk or regulatory concerns. Expect cross-functional calls, document review, and decision logs more than patient-facing care.
No. The listing has remote set to 0 and places the job in Parsippany, Morris County, New Jersey.
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Website: systemone.com
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System One seeks a Director Medical Monitor to provide clinical oversight and strategic medical leadership for assigned clinical research studies from initiation through completion in our Parsippany, New Jersey office. About the Role As Director Medical Monitor, you will lead medical oversight activities across clinical studies, ensuring regulatory compliance, participant safety, and study integrity throughout the study lifecycle. This hands-on leadership position leverages your medical expertise to drive study success and protect research participants. What You'll Do Oversee medical monitoring and clinical direction for assigned clinical research studies from startup through closeout Review, develop, and refine study protocols and protocol amendments in collaboration with sponsors and investigator teams Evaluate and approve informed consent forms for safety, clarity, and regulatory compliance Lead preparation of clinical study reports and regulatory documentation Serve as the primary medical contact and clinical decision-maker for assigned studies Conduct ongoing medical assessments and safety reviews throughout the study period Ensure compliance with GCP guidelines, FDA regulations, and sponsor requirements Mentor clinical monitoring staff on medical protocol requirements and standards What We're Looking For Medical degree (MD or DO) with active US medical license Minimum 5+ years of clinical research, medical monitoring, or related clinical experience Demonstrated expertise in clinical trial protocols, regulatory requirements, and medical oversight Strong independent medical judgment and clinical assessment capability Excellent communication and ability to serve as medical authority with study sponsors and research sites Detail-oriented approach to protocol compliance and study documentation Leadership experience and ability to guide clinical teams About System One System One is a clinical research organization supporting rigorous, compliant clinical studies. We partner with sponsors, research sites, and healthcare professionals to advance medical knowledge and improve patient outcomes. How to Apply To apply for this Director Medical Monitor position, submit your resume and cover letter through this job listing.
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