Risk

• Lead and oversee Risk-Based Quality Management (RBQM) activities for assigned clinical studies
• Develop and maintain Central Monitoring Plans, ensuring appropriate approvals and alignment with study strategies
• Support creation and ongoing review of study risk assessments with cross-functional teams
• Facilitate identification, tracking, and monitoring of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs)
• Perform centralized monitoring reviews to identify trends, outliers, signals, and potential risks, recommending actions to study teams
• Maintain central monitoring dashboards and support ongoing monitoring throughout the study lifecycle
• Deliver training and guidance to study teams on RBQM strategies, monitoring approaches, and risk management processes
• Contribute to inspection readiness, budget awareness, sponsor interactions, audits, and project-related meetings
• Collaborate with global teams and internal stakeholders and sponsors to support inspection-ready processes and clinical trial quality

Explore Risk and Central Monitoring Associate Manager at Worldwide Clinical Trials. Review requirements and application details.

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