Director, Clinical Trial Quality & Risk Management, National Center for Clinical

Department:10010 NCCT (National Center for Clinical Trials) - AdministrationStatus:Full timeBenefits Eligible:YesHours Per Week:40Schedule Details/Additional Information:N/APay Range:$63.45 - $95.20Major Responsibilities:Clinical Quality Management & Risk-Based Quality FrameworkDesign, implement, and continuously refine the NCCT clinical quality management approach, aligned with enterprise regulatory, QA, and compliance standardsDevelop and operationalize risk-based quality management (RBQM) frameworks across clinical trial activitiesDefine andmaintainrisk assessment methodologies to proactivelyidentifyand mitigate operational and compliance risksEstablish standardized quality control processes embedded within clinical trial workflowsEnsure consistent application of quality practices across sites, studies, and functional teams Centralized Monitoring & Data-Driven Quality OversightDevelop and oversee centralized statistical monitoring programs toidentifydata anomalies, trends, and potential quality risksEstablish key quality indicators (KQIs) and dashboards tomonitorperformance across clinical trialsProvide real-time visibility into quality trends, risks, and performance gaps to NCCT leadershipPartner with Technology and data teams to enhance analytics, reporting infrastructure, and automation capabilitiesLeverage data to enable proactive decision-making and early issue detection Quality Control, Issue Management & Continuous ImprovementOversee quality control activities across clinical trial processes to ensure adherence to SOPs and protocol requirementsIdentify, track, and trend deviations, issues, and quality events across studies and sitesCoordinate root cause analysis and corrective and preventive actions (CAPA) in collaboration with functional teams and enterprise QA as appropriateFacilitate 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 performanceEnsure quality insights are translated into standardized processes and best practices Training, Investigator Enablement & Quality CulturePartner with Clinical Trial Operations and enterprise stakeholders to reinforce training and competency development for investigators and study teamsIdentifycommon quality risks associated with new or inexperienced investigators and implement mitigation strategiesSupport development of training reinforcement mechanisms aligned with protocol adherence and regulatory expectationsPromote a culture of quality, accountability, and operational discipline across NCCTEnterprise Quality, Regulatory & Compliance CoordinationServe as the primary NCCT interface with enterprise regulatory, research QA, and corporate compliance functionsParticipate in cross-functional governance forums andestablishstandardized escalation and communication pathways between NCCT and enterprise shared service partnersEnsure alignment with enterprise policies, SOPs, and regulatory frameworks without duplicating oversight functionsProactively engage enterprise stakeholders in the design and execution of new operational models, studies, and initiativesCoordinate escalation of quality issues, risks, and compliance concerns throughappropriate enterprisechannelsSupport definition and execution of clear roles, responsibilities, and escalation pathways (e.g., RACI models) across NCCT and enterprise partnersPartner 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 & GovernancePartner with enterprise QA and compliance teams to support inspection readiness and audit preparednessProvideoperational quality insights, documentation, and data to support internal and external auditsParticipate in enterprise quality governance forums, including risk assessments, quality councils, and performance reviewsEnsure NCCT maintains readiness for regulatory inspections through consistent application of quality practicesSupport responses to audit findings and regulatory inquiries in coordination with enterprise stakeholders Cross-Functional Integration & Operational AlignmentEmbed quality principles across NCCT functions, including Clinical Trial Operations, Real World Data &Evidence, Business Development, and TechnologyEnsure quality considerations are incorporated into study feasibility, start-up, execution, and closeoutCoordinate with enterprise shared services (e.g., Legal, Compliance, Finance, IT, Lab, Pharmacy) to address cross-functional risksIdentifyand resolve gaps in ownership, communication, and execution across functionsSupport scalable, standardized operating models that enable efficient growth without compromising qualityLicensure, Registration, a