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 andmaintainrisk assessment methodologies to proactivelyidentifyand 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 toidentifydata anomalies, trends, and potential quality risks

• Establish key quality indicators (KQIs) and dashboards tomonitorperformance 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

• Identifycommon 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 andestablishstandardized 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 throughappropriate enterprisechannels

• 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, asappropriate, to ensure relevant clinical trial quality and safety insights are communicated throughestablishedenterpriselearning and escalation pathways

Inspection Readiness, Audit Support & Governance

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

• Provideoperational 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

• Identifyand 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

• Experienceoperatingwithin 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

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

• Proficiencyin centralized monitoring and data-driven quality approaches

• Ability toidentify, 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 tooperateeffectively in fast-paced, evolving environments with a high degree of accountability