Director, Clinical Trial Delivery, National Center for Clinical Trials (NCCT)
About The Position
The Director, Clinical Trial Delivery, National Center for Clinical Trials (NCCT) leads the enterprise delivery of industry-sponsored clinical trials across Advocate Health, ensuring operational excellence, quality, and consistent execution from study activation through closeout. This role directs a team responsible for therapeutic area portfolios, providing leadership, coaching, performance management, and workforce planning. The Director ensures that activated studies are operationally ready to enroll participants within established enterprise service level expectations and actively removes barriers that delay study execution. They oversee study performance to achieve key operational metrics, including study activation timelines, first patient visit, enrollment, study closeout, and investigator and coordinator satisfaction. Additionally, the Director establishes, implements, and continuously improves standardized enterprise workflows, operational playbooks, and best practices to create consistent trial delivery across hospitals, clinics, and service lines. They oversee operational capacity planning, study assignment, and resource allocation to optimize workload distribution and support portfolio growth. The role involves partnering with enterprise recruitment, regulatory, contracting, finance, quality, compliance, pharmacy, laboratory, and clinical service line leaders to ensure seamless study delivery. Collaboration with investigators, department leaders, sponsors, CROs, and biotechnology partners is crucial for resolving operational issues, improving study performance, and strengthening strategic relationships. The Director ensures compliance with applicable regulations, Good Clinical Practice (GCP), institutional policies, sponsor requirements, and enterprise quality standards while maintaining audit readiness. They design and direct the work of their assigned areas, selecting, coaching, and developing teams, setting objectives that align with organizational strategy, and managing organizational talent through performance management, succession planning, and development. The role also involves developing and/or recommending operating and capital budgets and controlling expenditures within approved budget objectives. The Director is responsible for understanding and adhering to the organization's Code of Ethical Conduct and ensuring compliance with applicable policies, regulations, and laws.
Requirements
- Bachelor's degree in healthcare administration, business, nursing, life sciences, public health, or a related field required.
- Minimum of 7 years of clinical research experience, with 5 years of progressive leadership experience in clinical research operations, including management of multi-site or enterprise clinical trial programs.
- Demonstrated experience leading Clinical Trial Managers, Project Managers, Clinical Research Site Managers, Research Coordinators, or comparable operational leadership teams.
- Experience overseeing large portfolios of industry-sponsored clinical trials; experience managing 100+ concurrent studies preferred.
- Demonstrated ability to lead organizational change, improve operational performance, and build high-performing teams within large health systems and/or research networks.
- Demonstrated success implementing standardized operational workflows across multiple hospitals, research sites, or healthcare organizations.
- Experience with operational capacity planning, performance management, and resource allocation in a complex healthcare environment.
- Strong knowledge of ICH-GCP, FDA regulations, clinical research compliance, and quality management principles.
- Experience collaborating with investigators, clinical service lines, sponsors, CROs, and cross-functional healthcare leaders.
- Experience using enterprise clinical research technologies such as Huron, CTMS platforms, Florence, or comparable systems.
- Highly developed organizational, problem solving and analytical skills, with the ability to prioritize time-sensitive tasks.
- Ability to work independently, make decisions and ensure project progress.
Nice To Haves
- Master's degree
- Current or previous Certified Clinical Research Coordinator (CCRC)
- Lean, Six Sigma, Operational Excellence, or change management
Responsibilities
- Leads enterprise delivery of industry-sponsored clinical trials from study activation through closeout across Advocate Health, ensuring operational excellence, quality, and consistent execution.
- Directs a team responsible for therapeutic area portfolios, providing leadership, coaching, performance management, and workforce planning.
- Ensures activated studies are operationally ready to enroll participants within established enterprise service level expectations and removes barriers that delay study execution.
- Oversees study performance to achieve key operational metrics, including study activation timelines, first patient visit, enrollment, study closeout, and investigator and coordinator satisfaction.
- Establishes, implements, and continuously improves standardized enterprise workflows, operational playbooks, and best practices to create consistent trial delivery across hospitals, clinics, and service lines.
- Oversees operational capacity planning, study assignment, and resource allocation to optimize workload distribution and support portfolio growth.
- Partners with enterprise recruitment, regulatory, contracting, finance, quality, compliance, pharmacy, laboratory, and clinical service line leaders to ensure seamless study delivery.
- Collaborates with investigators, department leaders, sponsors, CROs, and biotechnology partners to resolve operational issues, improve study performance, and strengthen strategic relationships.
- Ensures compliance with applicable regulations, Good Clinical Practice (GCP), institutional policies, sponsor requirements, and enterprise quality standards while maintaining audit readiness.
- Designs and directs the work of the assigned area(s) of responsibility. Selects, coaches, and develops teams, setting objectives that align with organizational strategy to inspire and motivate the teams. Manages organizational talent through performance management, succession planning, and development. Designs and directs processes by which team and individual performance are recognized, feedback is consistently delivered, and performance is systematically improved.
- Develops and/or recommends operating and capital budgets and controls expenditures within approved budget objectives.
- Responsible for understanding and adhering to the organization's Code of Ethical Conduct and for ensuring that people actions, and the actions of employees supervised, comply with the policies, regulations, and laws applicable to the organization's business.
Benefits
- Comprehensive suite of Total Rewards: benefits and well-being programs
- Competitive compensation
- Generous retirement offerings
- Programs that invest in your career development
- 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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What This Job Offers
Job Type
Full-time
Career Level
Director
