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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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