Fortrea seeks a Manager for Centralized Monitoring to oversee clinical trial monitoring activities, lead a team of 8-20 staff, and ensure compliance with regulatory standards. The role involves analyzing trip reports, identifying study risks, managing central monitoring strategies, and serving as a key liaison between clinical research associates and project leadership.
Responsibilities
Review trip reports and identify risks, trends, and safety concerns for escalation to study teams
Lead centralized monitoring activities across multiple studies at site, regional, and study levels
Manage and develop a team of 8-20 staff including performance management and training
Develop central monitoring plans, configure monitoring tools, and define risk thresholds
Serve as primary contact for general clinical trial leads and project managers on monitoring status
Requirements
Experience managing centralized or risk-based monitoring programs in clinical trials
Demonstrated people leadership and team management capability
Knowledge of ICH-GCP guidelines and clinical trial regulatory requirements
Proficiency with monitoring tools, dashboards, and data analysis
Strong communication and stakeholder management skills
Experience with document management and protocol deviation tracking