The Clinical Quality Management (CQM) Lead is essential in implementing risk-based quality management for clinical trials. Key responsibilities include leading the identification of critical to quality factors, leading quality risk identification, prioritization and mitigation, and overseeing predefined acceptable ranges (e.g., Quality Tolerance Limits - QTLs). The CQM Lead ensures continuous quality improvement and maintains inspection readiness at all times, providing guidance on Good Clinical Practice (GCP) quality principles.