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.