Director, Clinical Trial Quality & Risk Management, National Center for Clinical Trials (NCCT)

Clinical Quality Management & Risk-Based Quality Framework 

• Design, implement, and continuously refine the NCCT clinical quality management approach, aligned with enterprise regulatory, QA, and compliance standards 

• Develop and operationalize risk-based quality management (RBQM) frameworks across clinical trial activities 

• Define and maintain risk assessment methodologies to proactively identify and mitigate operational and compliance risks 

• Establish standardized quality control processes embedded within clinical trial workflows 

• Ensure consistent application of quality practices across sites, studies, and functional teams 

Centralized Monitoring & Data-Driven Quality Oversight 

• Develop and oversee centralized statistical monitoring programs to identify data anomalies, trends, and potential quality risks 

• Establish key quality indicators (KQIs) and dashboards to monitor performance across clinical trials 

• Provide real-time visibility into quality trends, risks, and performance gaps to NCCT leadership 

• Partner with Technology and data teams to enhance analytics, reporting infrastructure, and automation capabilities 

• Leverage data to enable proactive decision-making and early issue detection 

Quality Control, Issue Management & Continuous Improvement 

• Oversee quality control activities across clinical trial processes to ensure adherence to SOPs and protocol requirements 

• Identify, track, and trend deviations, issues, and quality events across studies and sites 

• Coordinate root cause analysis and corrective and preventive actions (CAPA) in collaboration with functional teams and enterprise QA as appropriate 

• Facilitate operational ownership and escalation of corrective and preventative actions (CAPAs), protocol deviations, and quality risks in alignment with enterprise governance and decision-making structures.  

• Drive continuous improvement initiatives to address systemic issues and enhance operational performance 

• Ensure quality insights are translated into standardized processes and best practices 

Training, Investigator Enablement & Quality Culture 

• Partner with Clinical Trial Operations and enterprise stakeholders to reinforce training and competency development for investigators and study teams 

• Identify common quality risks associated with new or inexperienced investigators and implement mitigation strategies 

• Support development of training reinforcement mechanisms aligned with protocol adherence and regulatory expectations 

• Promote a culture of quality, accountability, and operational discipline across NCCT 

Enterprise Quality, Regulatory & Compliance Coordination 

• Serve as the primary NCCT interface with enterprise regulatory, research QA, and corporate compliance functions 

• Participate in cross-functional governance forums and establish standardized escalation and communication pathways between NCCT and enterprise shared service partners 

• Ensure alignment with enterprise policies, SOPs, and regulatory frameworks without duplicating oversight functions 

• Proactively engage enterprise stakeholders in the design and execution of new operational models, studies, and initiatives 

• Coordinate escalation of quality issues, risks, and compliance concerns through appropriate enterprise channels 

• Support definition and execution of clear roles, responsibilities, and escalation pathways (e.g., RACI models) across NCCT and enterprise partners 

• Partner with enterprise patient safety and quality teams, as appropriate, to ensure relevant clinical trial quality and safety insights are communicated through established enterprise learning and escalation pathways 

Inspection Readiness, Audit Support & Governance 

• Partner with enterprise QA and compliance teams to support inspection readiness and audit preparedness 

• Provide operational quality insights, documentation, and data to support internal and external audits 

• Participate in enterprise quality governance forums, including risk assessments, quality councils, and performance reviews 

• Ensure NCCT maintains readiness for regulatory inspections through consistent application of quality practices 

• Support responses to audit findings and regulatory inquiries in coordination with enterprise stakeholders 

Cross-Functional Integration & Operational Alignment 

• Embed quality principles across NCCT functions, including Clinical Trial Operations, Real World Data & Evidence, Business Development, and Technology 

• Ensure quality considerations are incorporated into study feasibility, start-up, execution, and closeout 

• Coordinate with enterprise shared services (e.g., Legal, Compliance, Finance, IT, Lab, Pharmacy) to address cross-functional risks 

• Identify and resolve gaps in ownership, communication, and execution across functions 

• Support scalable, standardized operating models that enable efficient growth without compromising quality 

• 7+ years of experience in clinical research, quality management, or related roles within healthcare or life sciences 

• Demonstrated experience in clinical quality management, risk-based monitoring, or centralized monitoring 

• Experience operating within regulated environments (e.g., FDA, ICH-GCP) 

• Experience working within complex, matrixed organizations 

• Experience collaborating with regulatory, compliance, or audit functions in a healthcare or research setting 

• Strong knowledge of clinical trial operations, GCP, and regulatory requirements 

• Experience designing and implementing risk-based quality management (RBQM) frameworks 

• Proficiency in centralized monitoring and data-driven quality approaches 

• Ability to identify, assess, and manage operational and compliance risks across complex systems 

• Strong understanding of quality control processes, deviation management, and CAPA coordination 

• Ability to partner effectively with enterprise regulatory, QA, and compliance stakeholders 

• Strong process improvement mindset with experience scaling operational infrastructure 

• Excellent communication and stakeholder management skills, with the ability to influence across functions 

• Ability to operate effectively in fast-paced, evolving environments with a high degree of accountability