Associate Director, Clinical Quality Management

Risk-Based Quality Management (RBQM) Leadership

Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance.

Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors.

Integrate RBQM principles into study planning, execution, oversight, and close-out activities.

Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy.

Central Risk Identification, Monitoring & Mitigation

Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks.

Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials.

Oversee centralized risk monitoring and trending to enable early detection of critical risks.

Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons Learned & Risk Library Management (Core Ownership).

Quality Oversight & Regulatory Compliance

Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs.

Provide centralized quality oversight across trials, CROs, and vendors.

Support audit and inspection readiness activities, including:

• Risk-based inspection preparation
• Impact assessments
• CAPA development and effectiveness checks

Vendor & CRO Risk Oversight

Design and implement risk-based oversight strategies for CROs and external vendors.

Monitor vendor performance using quality metrics and risk indicators.

Lead or support quality governance discussions with external partners.

Ensure vendor-related risks are integrated into the central risk library and lessons learned framework.

Data-Driven Quality & Continuous Improvement

Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making.

Generate enterprise-level risk trend reports and insights for senior leadership.

Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned.

Champion a culture of proactive quality and continuous improvement across Clinical Operations.

Cross-Functional Collaboration & RBQM Expertise

Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance.

Provide RBQM training and coaching to study teams and cross-functional stakeholders.

Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics.

Participate as an observing member on assigned study teams to provide real-time quality and risk support.

SOP Management & Governance Support

Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates.

Support governance activities, senior management reporting, and quality metrics standardization.

Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.

Provide real-time quality and risk support.