Central Monitoring, Manager

About the Role

The Manager, Central Monitoring is accountable for centralized monitoring activities for global and/or complex trials, analytical data review of key risk and/or operational performance data and presenting as an integral member of the Clinical Study team for clinical development studies.

Key Responsibilities

• Review and interpret Key Risk Indicator (KRI) and Key Performance Indicator (KPI) data housed in analytical tools
• Conduct comprehensive review of supplemental operational data, trends and issues
• Support several studies within a therapeutic area and program-level
• Work closely with other Central Monitors and Centralized Data Risk Analysts (CDRAs)
• Ensure effective identification, conduct and reporting of central monitoring activities
• Participate in development and refinement of the Study Quality Risk Assessment and Control Tracker (QRACT)
• Lead creation of the Central Monitoring Plan with study-specific alignment
• Contribute to process improvement and innovation activities
• Participate in industry collaborations in central monitoring capabilities

Requirements

• Minimum one year of direct central monitoring experience