[Hiring] 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.