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 ensures 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 resolved promptly.

Vendor Qualification and Oversight : Responsible for conducting qualification assessment of clinical service providers to ensure compliance with regulatory requirements and internal processes. Work closely with internal stakeholders and service providers QA representatives to ensure effective oversight and continuous monitoring.

Risk Management : Review and assess study risks in collaboration with stakeholders. Facilitate the identification of study-specific risks and critical to quality factors. Monitor KQIs on a monthly to quarterly basis through analytics and provide insights to stakeholders. Perform trending analyses on KQIs, and quality events to identify patterns and risks. Communicate potential quality issues identified during KQI reviews and support mitigation planning.

Audit and Inspection Readiness : Provide input to audit management for risk assessments to support the generation of the audit plan. Support stakeholders in preparing for audits, including site and service provider’s audits, regulatory inspections, and internal audits. Review CAPAs related to audits and inspections to ensure thoroughness and alignment with compliance requirements.

Quality Events and Deviations Management : Support stakeholders in managing quality events and deviations, including investigations and root cause analyses. Assist in the development and implementation of CAPAs to address identified quality events and deviations.

Team Training and Compliance Oversight : Perform follow-up on study document training compliance for the Clinical Trial Team (CTT). Ensure the CTT team remains up to date with protocol training, and study-specific updates.

Continuous Improvement : Analyze quality trends from KQI reviews, audits, and quality events to recommend continuous improvement initiatives. Provide training and awareness sessions to stakeholders on GCP compliance, risk management, and quality oversight.