Director, Clinical Trial Contracts

Atrium Health Wake Forest Baptist

Charlotte (NC)

Remote

USD 114,000 - 171,000

Full time

5 days ago
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Job summary

Atrium Health Wake Forest Baptist seeks an experienced leader to oversee enterprise clinical trial contracting activities, directing the negotiation and management of CTAs, CDAs, and MCTAs while driving efficiency and compliance.

The role requires collaboration with legal, finance, and research affiliates, development of standardized templates, and leadership of staff to accelerate study activation in a regulated healthcare environment.

Qualifications

  • 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 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.
  • Strong contract negotiation, conflict resolution, and stakeholder management skills.
  • Demonstrated ability to lead organizational change initiatives and drive continuous process improvement.

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.

Skills

Contract negotiation
Leadership
Stakeholder management
Problem solving
Communication skills

Education

Bachelor's degree
Master's degree in Business Administration or Healthcare Administration
Professional certifications in lieu of degree

Tools

Microsoft Office
CTMS platforms
Huron Research Suite
Florence

Job description

Atrium Health Wake Forest Baptist seeks an experienced leader to oversee enterprise clinical trial contracting activities, directing the negotiation and management of CTAs, CDAs, and MCTAs while driving efficiency and compliance.

The role requires collaboration with legal, finance, and research affiliates, development of standardized templates, and leadership of staff to accelerate study activation in a regulated healthcare environment.

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