Senior Central Monitor

Job Summary

To support clinical monitoring teams, the full-time Senior Central Monitor will perform remote site monitoring and management activities, ensuring compliance with regulatory guidelines and project plans while utilizing centralized data and reporting tools.

Key responsibilities

• Conduct remote site monitoring and management activities in accordance with FDA regulations, ICH GCPs, and project plans
• Assist the study monitoring team in implementing strategies and processes to ensure quality and timely study delivery
• Support data collection and report generation for tracking recruitment, enrollment, and other key metrics for clinical trial execution

Required qualifications

• Bachelor's degree preferred, or equivalent training and experience
• Minimum 3 years of experience in study coordination and in-house monitoring within the Biotechnology or Pharmaceutical industries
• Proficiency in clinical trial execution systems such as Electronic Document Management Systems and Clinical Trial Management Systems
• Understanding of quality assurance concepts and practices
• Experience with Cluepoints RBQM System is desired