Director, Clinical Trial Delivery, National Center for Clinical Trials (NCCT)

About the role

The Director of Clinical Trial Delivery leads the operational execution and performance of industry-sponsored clinical trials across the National Center for Clinical Trials (NCCT). This leader ensures studies are delivered efficiently, consistently, and with the highest standards of quality from activation through closeout. The role drives operational excellence through standardized processes, capacity optimization, performance management, and barrier removal, while partnering with investigators, operational leaders, service lines, research administration, recruitment teams, sponsors, and CROs to advance an enterprise clinical trials operating model.

Responsibilities

• Leads enterprise delivery of industry-sponsored clinical trials from study activation through closeout, 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 assigned areas, selecting, coaching, and developing teams to align objectives with organizational strategy.
• Manages organizational talent through performance management, succession planning, and development.
• Designs processes for consistent performance feedback and systematic improvement.
• Develops and/or recommends operating and capital budgets and controls expenditures within approved budget objectives.
• Ensures adherence to the organization's Code of Ethical Conduct and compliance with relevant policies, regulations, and laws.

Requirements

• Bachelor's degree in healthcare administration, business, nursing, life sciences, public health, or a related field.
• 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.

Skills

• 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.

Preferred Qualifications

• Master's degree.
• Current or previous Certified Clinical Research Coordinator (CCRC) certification.
• Experience with Lean, Six Sigma, Operational Excellence, or change management methodologies.

Physical Requirements and Working Conditions

• Primarily remote and office-based, requiring prolonged periods of sitting, computer use, and communication via telephone and video conferencing.
• Routine use of standard office equipment; minimal physical activity beyond typical office tasks, including occasional lifting of materials up to 10 pounds.
• Limited travel may be required for business meetings, conferences, or organizational events.