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

Major Responsibilities

• 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

Qualifications

• Bachelor’s degree in life sciences, healthcare, or a related field required
• 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

Knowledge, Skills & Abilities Required

• 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