Senior Medical Monitor

Job Summary

Providing medical oversight for Phase I-IV clinical trials, the full-time Senior Medical Monitor will review safety-related clinical data, support protocol development, and guide regulatory reporting while working remotely in the US.

Key responsibilities

• Provide medical oversight for clinical trials and observational studies, ensuring participant eligibility and safety
• Review and analyze adverse events and safety data, leading safety activities and participating in cross-functional meetings
• Guide the preparation of regulatory documents and safety reports, serving as a medical subject matter expert for project teams

Required qualifications

• Medical degree (MD, DO, or international equivalent)
• 5+ years of medical monitoring, clinical, or research experience
• Experience with protocol amendments and aggregate data review for clinical trials
• Excellent knowledge of medical terminology, clinical pharmacology, and regulatory guidelines (ICH, FDA, EMA)
• Strong scientific writing skills and proficiency with MS Office applications