Director, Clinical Trial Quality & Risk Management, National Center for Clinical Trials (NCCT)
Department:
10010 NCCT (National Center for Clinical Trials) - Administration
Status:
Full time
Benefits Eligible:
Yes
Hours Per Week:
40
Schedule Details/Additional Information:
N/A
Pay Range:
$63.45 - $95.20
Major Responsibilities:
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 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 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
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 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 through appropriate enterprise channels
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, as appropriate, to ensure relevant clinical trial quality and safety insights are communicated through established enterprise learning and escalation pathways
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 (e.g., Legal, Compliance, Finance, IT, Lab, Pharmacy) 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
Licensure, Registration, and/or Certification Required:
None Required.
Education Required:
Bachelor’s degree in life sciences, healthcare, or a related field required
Experience Required:
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
Knowledge, Skills & Abilities Required:
Strong knowledge of clinical trial operations, GCP, and regulatory requirements
Experience designing and implementing risk-based quality management (RBQM) frameworks
Proficiency in centralized monitoring and data-driven quality approaches
Ability to identify, 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 to operate effectively in fast-paced, evolving environments with a high degree of accountability
Preferred Job Requirements
Preferred Education:
Advanced degree (MS, MPH, or equivalent) preferred
Preferred Certification / License:
Relevant certifications in clinical research or quality (e.g., CCRA, CCRP, RAC) preferred but not required
DISCLAIMER
All responsibilities and requirements are subject to possible modification to reasonably accommodate individuals with disabilities.
This job description in no way states or implies that these are the only responsibilities to be performed by an employee occupying this job or position. Employees must follow any other job-related instructions and perform any other job-related duties requested by their leaders.
Our Commitment to You:
Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:
Compensation
Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
Premium pay such as shift, on call, and more based on a teammate's job
Incentive pay for select positions
Opportunity for annual increases based on performance
Benefits and more
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
Note: Eligibility for programs listed above may depend on your FTE or status (e.g., full-time, part-time, per diem, temporary, etc.); please ask a Recruiter for more information during an interview.
About Advocate Health
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. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.
10010 NCCT (National Center for Clinical Trials) - Administration
Status:
Full time
Benefits Eligible:
Yes
Hours Per Week:
40
Schedule Details/Additional Information:
N/A
Pay Range:
$63.45 - $95.20
Major Responsibilities:
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 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 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
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 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 through appropriate enterprise channels
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, as appropriate, to ensure relevant clinical trial quality and safety insights are communicated through established enterprise learning and escalation pathways
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 (e.g., Legal, Compliance, Finance, IT, Lab, Pharmacy) 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
Licensure, Registration, and/or Certification Required:
None Required.
Education Required:
Bachelor’s degree in life sciences, healthcare, or a related field required
Experience Required:
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
Knowledge, Skills & Abilities Required:
Strong knowledge of clinical trial operations, GCP, and regulatory requirements
Experience designing and implementing risk-based quality management (RBQM) frameworks
Proficiency in centralized monitoring and data-driven quality approaches
Ability to identify, 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 to operate effectively in fast-paced, evolving environments with a high degree of accountability
Preferred Job Requirements
Preferred Education:
Advanced degree (MS, MPH, or equivalent) preferred
Preferred Certification / License:
Relevant certifications in clinical research or quality (e.g., CCRA, CCRP, RAC) preferred but not required
DISCLAIMER
All responsibilities and requirements are subject to possible modification to reasonably accommodate individuals with disabilities.
This job description in no way states or implies that these are the only responsibilities to be performed by an employee occupying this job or position. Employees must follow any other job-related instructions and perform any other job-related duties requested by their leaders.
Our Commitment to You:
Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more – so you can live fully at and away from work, including:
Compensation
Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
Premium pay such as shift, on call, and more based on a teammate's job
Incentive pay for select positions
Opportunity for annual increases based on performance
Benefits and more
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
Note: Eligibility for programs listed above may depend on your FTE or status (e.g., full-time, part-time, per diem, temporary, etc.); please ask a Recruiter for more information during an interview.
About Advocate Health
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. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.