Leading nationwide provider of substance use treatment offering a full continuum of care. #FreedomFromAddiction
Director, Clinical Trial Quality & Risk Management
Location
United States
Posted
2 days ago
Salary
$63 - $95 / hour
Seniority
Lead
No structured requirement data.
Job Description
Director, Clinical Trial Quality & Risk Management
American Addiction Centers
Role Description The role involves managing clinical quality and risk-based quality frameworks, ensuring compliance with regulatory standards, and promoting a culture of quality across clinical trials. - Clinical Quality Management & Risk-Based Quality Framework - Design, implement, and continuously refine the NCCT clinical quality management approach. - 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. - Facilitate operational ownership and escalation of CAPAs, protocol deviations, and quality risks. - 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. - Ensure alignment with enterprise policies, SOPs, and regulatory frameworks. - 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. - Partner with enterprise patient safety and quality teams to ensure relevant clinical trial quality and safety insights are communicated. - 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 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. Requirements - 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. Benefits - Paid Time Off programs. - Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability. - Flexible Spending Accounts for eligible health care and dependent care expenses. - Family benefits such as adoption assistance and paid parental leave. - Defined contribution retirement plans with employer match and other financial wellness programs. - Educational Assistance Program.
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