Manager, Centralized Monitoring
Fortrea
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 global 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
Vacante publicada el 8 días atrás
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