Medical Monitor Job Description

Job Title: Medical Monitor

Work Location: Santa Clara County, California

Summary:

The Medical Monitor is responsible for providing expert medical oversight and guidance throughout the conduct of clinical studies, ensuring participant safety, protocol compliance, and high-quality data collection. This role involves collaboration with clinical teams, safety committees, and site staff to address medical questions and support the successful execution of clinical trials, particularly in the CNS/psychiatry therapeutic area.

Responsibilities:

• Deliver medical oversight for clinical study conduct, acting as the primary contact for site medical and eligibility inquiries.
• Evaluate participant eligibility, protocol deviations, and safety data, supporting ongoing benefit-risk assessments during studies.
• Assess adverse events and serious adverse events, collaborating with pharmacovigilance to determine causality and expectedness.
• Participate in safety monitoring activities, including signal detection and preparation for data safety monitoring boards and safety committees.
• Provide guidance on suicidality monitoring and psychiatric safety, with a focus on CNS clinical trials.
• Review protocols, investigator brochures, and safety documents with a focus on medical accuracy and inspection readiness.
• Respond promptly to time-sensitive medical queries and provide medical coverage for clinical sites in the US and UK, including urgent situations.
• Advise on the use of psychiatric rating scales and address placebo-response considerations in clinical trial settings.

Qualifications:

• MD or international equivalent with active or prior clinical experience.
• Experience in clinical-trial medical monitoring for interventional studies.
• Strong knowledge of ICH-GCP guidelines and drug safety principles.
• Demonstrated sound judgment and responsiveness for urgent medical queries.
• Availability to provide medical coverage across US and UK clinical sites.
• Background in psychiatry or CNS, with experience in depression or treatment-resistant depression trials preferred.
• Familiarity with psychiatric rating scales and placebo-response issues is desirable.

Published Category: Clinical Research