Mission

The Clinical Development Quality Manager (CDQM) is responsible for ensuring quality oversight across clinical development activities and supporting the maintenance of GCP compliance. This role supports stakeholders in vendor qualification, study risk management, quality oversight, team training compliance, and coaching as needed. Responsibilities include monitoring Key Quality Indicators (KQIs), analyzing trends in quality events, ensuring protocol adherence and providing support for quality events, audits, and corrective and preventive actions (CAPAs). The CDQM measures proactive identification and mitigation of risks to maintain the integrity of clinical trial data and protect patient safety.

Main Responsibilities

GCP Support and Oversight

• Provide GCP support and guidance to clinical development stakeholders.
• Maintain and manage the CDQM GCP query log, ensuring all GCP-related queries are logged, tracked, and resolve...