Opportunity Description
Manager, Risk-Based Quality Management
The Role:
The Manager, Risk-Based Quality Management (RBQM) plays a critical cross-functional role in ensuring the quality and compliance of clinical trial execution by leading efforts across all components of RBQM: risk management, central monitoring, and monitoring strategy and oversight.
This role is accountable for driving effective risk-based approaches that protect patient safety, ensure data integrity, and enhance operational efficiency. The Manager partners closely with internal teams and CROs to align execution with risk and quality expectations throughout the clinical trial lifecycle.
Key responsibilities include:
Risk Management Execution
+ Plan and Lead study- and program-level risk assessments and discussions, ensuring Critical to Quality (CTQ) factors, Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), and mitigation actions are consistently applied and tracked. Champion risk-based approaches in p...
The Role:
The Manager, Risk-Based Quality Management (RBQM) plays a critical cross-functional role in ensuring the quality and compliance of clinical trial execution by leading efforts across all components of RBQM: risk management, central monitoring, and monitoring strategy and oversight.
This role is accountable for driving effective risk-based approaches that protect patient safety, ensure data integrity, and enhance operational efficiency. The Manager partners closely with internal teams and CROs to align execution with risk and quality expectations throughout the clinical trial lifecycle.
Key responsibilities include:
Risk Management Execution
+ Plan and Lead study- and program-level risk assessments and discussions, ensuring Critical to Quality (CTQ) factors, Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), and mitigation actions are consistently applied and tracked. Champion risk-based approaches in p...
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