Associate Director, Contracts - National Center for Clinical Trials (NCCT)

Job Description Summary:

Provides operational leadership and oversight for enterprise clinical trial contracting activities supporting industry-sponsored clinical research across Advocate Health and Wake Forest University School of Medicine. Responsible for directing contract administration operations, supervising contracting personnel, ensuring efficient negotiation and execution of clinical research agreements, monitoring performance metrics, implementing process improvements, and collaborating with stakeholders to accelerate study activation while maintaining compliance with institutional, regulatory, and legal requirements.

Major Responsibilities:

• Provides operational leadership and oversight for enterprise clinical research contracting activities supporting industry-sponsored clinical research, ensuring timely negotiation, execution, and administration of clinical research agreements.
• Designs and directs the work of the clinical trial contracts team, including selection, coaching, development, performance management, and workload allocation for contract administration staff.
• Oversees negotiation, review, execution, and management of Clinical Trial Agreements (CTAs), Confidential Disclosure Agreements (CDAs), Master Clinical Trial Agreements (MCTAs), amendments, and other research-related agreements.
• Monitors contract performance metrics, turnaround times, service levels, and operational workloads; develops and implements strategies to improve efficiency, quality, and customer service.
• Develops, implements, and maintains standardized contract templates, workflows, negotiation strategies, and best practices that enhance consistency and reduce study startup timelines.
• Collaborates with investigators, research administration, legal counsel, finance, compliance, regulatory affairs, and operational stakeholders to facilitate study activation and resolve complex contractual issues.
• Provides guidance and resolution for high-risk or complex contractual negotiations involving intellectual property, publication rights, indemnification, confidentiality, subject injury, data use, and related provisions.
• Supports implementation, optimization, and utilization of research administration systems and technologies that facilitate contract management, reporting, and operational efficiency.
• Prepares and presents operational reports, dashboards, and performance analyses to research administration leadership to support strategic planning and decision-making.
• Responsible for understanding and adhering to the organization's Code of Ethical Conduct and ensuring that contracting activities and supervised employees comply with organizational policies, applicable regulations, and governing laws.

Education Required:

• Bachelor's degree required. In some circumstances, equivalent years of direct research administration experience or applicable professional certifications may be considered in lieu of a bachelor's degree.
  

Work Experience Required:

• Minimum seven (7) years of progressively responsible experience in clinical research, research administration, clinical trial contracting, grants and contracts administration, or related healthcare research environment.
• Minimum three (3) years of leadership, supervisory, or management experience overseeing staff involved in research administration, contracting, or related operational functions.

Knowledge, Skills & Abilities Required:

• Knowledge of clinical research regulations, sponsor-funded research administration processes, and clinical trial agreement requirements.
• Knowledge of Clinical Trial Agreements, Confidential Disclosure Agreements, Master Clinical Trial Agreements, amendments, and related research contracts.
• Knowledge of contractual provisions including intellectual property, publication rights, confidentiality, subject injury, indemnification, insurance, and data use terms.
• Strong contract negotiation, conflict resolution, and stakeholder management skills.
• Ability to analyze complex contractual language and communicate business, legal, and operational impacts to diverse audiences.
• Strong organizational, analytical, problem-solving, and decision-making skills.
• Ability to manage multiple priorities and competing deadlines in a fast-paced environment.
• Demonstrated leadership, coaching, mentoring, and personnel management abilities.
• Strong oral, written, and presentation communication skills.
• Proficiency with Microsoft Office applications and research administration technology platforms.
• Ability to evaluate operational metrics and implement process improvements that enhance efficiency, quality, and service delivery.

Physical Requirements and Working Conditions:

• Work is performed primarily in a professional office or remote office environment.
• Requires prolonged periods of sitting, computer use, and viewing monitors.
• Requires frequent verbal and written communication with internal and external stakeholders.
• Occasional travel for meetings, training, or organizational initiatives may be required.
• Must be able to move throughout office and meeting environments and perform required administrative functions.

Preferred Job Requirements

Preferred Education

• Master's degree in Business Administration, Healthcare Administration, Public Administration, Legal Studies, Research Administration, Life Sciences, or related field.

Preferred Experience

• Experience supporting enterprise-level clinical research contracting operations within an academic medical center, healthcare system, or research-intensive organization.
• Experience implementing operational improvements and process standardization initiatives.
• Experience utilizing Huron Research Suite, CTMS platforms, Florence, or other enterprise research administration systems.
• Experience developing performance metrics, dashboards, and operational reporting tools.

Preferred Knowledge/Skills/Abilities

• Advanced knowledge of clinical trial contracting, research administration operations, and industry-sponsored research.
• Knowledge of enterprise contract management systems and workflow optimization methodologies.
• Ability to lead organizational change initiatives and drive continuous process improvement.
• Demonstrated ability to build collaborative relationships across legal, compliance, finance, operational, and research functions.
• Strong strategic planning and operational execution skills.
• Advanced data analysis and performance management capabilities.

This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties.

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