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

📋 Description

• • The Director, Clinical Trial Quality & Risk Management will play a pivotal role in establishing and enhancing the quality framework for clinical trials conducted by the National Center for Clinical Trials (NCCT) within Advocate Health. This leadership position is crucial for ensuring the integrity, compliance, and efficiency of clinical research operations, ultimately contributing to the advancement of medical knowledge and patient care.
• • Design, implement, and continuously refine the NCCT's clinical quality management approach, ensuring alignment with enterprise regulatory, Quality Assurance (QA), and compliance standards. This involves developing and operationalizing robust risk-based quality management (RBQM) frameworks that are integrated across all clinical trial activities.
• • Define and maintain comprehensive risk assessment methodologies to proactively identify, evaluate, and mitigate potential operational and compliance risks throughout the lifecycle of clinical trials. This includes establishing standardized quality control processes that are embedded within daily clinical trial workflows to ensure consistent adherence to protocols and Standard Operating Procedures (SOPs).
• • Oversee the consistent application of quality practices across all participating sites, diverse studies, and various functional teams involved in clinical research, fostering a unified approach to quality.
• • Develop and lead centralized statistical monitoring programs designed to meticulously identify data anomalies, emerging trends, and potential quality risks in real-time. This involves establishing key quality indicators (KQIs) and performance dashboards to provide leadership with real-time visibility into quality trends, identified risks, and performance gaps across the NCCT's portfolio of clinical trials.
• • Partner closely with Technology and data analytics teams to enhance the infrastructure for data analysis, reporting capabilities, and automation, leveraging data to enable proactive decision-making and early detection of issues.
• • Oversee quality control activities across all clinical trial processes, ensuring strict adherence to SOPs and protocol requirements. This includes identifying, meticulously tracking, and trending deviations, issues, and quality events across studies and sites to identify systemic problems.
• • Coordinate thorough root cause analysis for identified issues and facilitate the implementation of effective corrective and preventive actions (CAPA) in collaboration with relevant functional teams and enterprise QA, ensuring accountability and resolution.
• • Facilitate operational ownership and timely escalation of CAPAs, protocol deviations, and quality risks, aligning with enterprise governance and decision-making structures to ensure swift and appropriate action.
• • Drive continuous improvement initiatives by translating quality insights into standardized processes and best practices, addressing systemic issues and enhancing overall operational performance and efficiency.
• • Partner with Clinical Trial Operations and other enterprise stakeholders to reinforce training and competency development for investigators and study teams, identifying common quality risks associated with new or inexperienced investigators and implementing targeted mitigation strategies.
• • Support the development of training reinforcement mechanisms that are directly aligned with protocol adherence and evolving regulatory expectations, promoting a strong culture of quality, accountability, and operational discipline across the entire NCCT.
• • Serve as the primary NCCT interface with enterprise regulatory, research QA, and corporate compliance functions, ensuring seamless communication and collaboration. Participate in cross-functional governance forums and establish standardized escalation and communication pathways between NCCT and enterprise shared service partners.
• • Ensure NCCT's operations are fully aligned with enterprise policies, SOPs, and regulatory frameworks, avoiding duplication of oversight functions while maintaining robust quality standards.
• • Proactively engage enterprise stakeholders in the design and execution of new operational models, studies, and initiatives, ensuring quality is a foundational element from inception.
• • Coordinate the escalation of quality issues, risks, and compliance concerns through appropriate enterprise channels, ensuring transparency and timely resolution.
• • Support the definition and execution of clear roles, responsibilities, and escalation pathways (e.g., RACI models) across NCCT and its enterprise partners, fostering clarity and accountability.
• • Partner with enterprise patient safety and quality teams to ensure relevant clinical trial quality and safety insights are communicated through established enterprise learning and escalation pathways.
• • Partner with enterprise QA and compliance teams to support inspection readiness and audit preparedness, providing necessary 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, contributing NCCT's perspective and ensuring alignment.
• • Ensure NCCT maintains consistent readiness for regulatory inspections through the diligent application of quality practices and support responses to audit findings and regulatory inquiries in coordination with enterprise stakeholders.
• • Embed quality principles across all NCCT functions, including Clinical Trial Operations, Real World Data & Evidence, Business Development, and Technology, ensuring quality is a shared responsibility.
• • Ensure quality considerations are thoroughly incorporated into all phases of study management, from feasibility and start-up through execution and closeout.
• • Coordinate with enterprise shared services (e.g., Legal, Compliance, Finance, IT, Lab, Pharmacy) to proactively identify and address cross-functional risks and ensure integrated solutions.
• • Identify and resolve gaps in ownership, communication, and execution across functions, promoting a collaborative and efficient operational environment.
• • Support the development and implementation of scalable, standardized operating models that enable efficient growth without compromising the highest standards of quality.
• • About the team or company: Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. It is a national leader in clinical innovation, health outcomes, consumer experience, and value-based care, serving nearly 6 million patients and engaged in hundreds of clinical trials and research studies.
• • What the person can learn or achieve in this role: This role offers a significant opportunity to shape and lead quality initiatives within a large, integrated health system, driving impactful improvements in clinical trial operations and contributing to the advancement of healthcare. The Director will gain extensive experience in risk-based quality management, data-driven oversight, and cross-functional collaboration within a complex organizational structure.
• • Compensation is competitive, with a pay range of $63.45 - $95.20 per hour, based on qualifications and experience.
• • Comprehensive benefits package including Paid Time Off, medical, dental, vision, life insurance, and disability coverage.
• • Opportunities for professional development, including an Educational Assistance Program and robust retirement offerings with employer match.