Site Contracts Lead

Overview

This role involves managing site contract activities for assigned clinical studies. The Site Contracts Lead ensures high-quality contract documentation, supports compliant execution of documents (including NDAs, Clinical Trial Agreements, and amendments), and partners with clients, country experts, and internal teams to meet study start-up timelines.

Responsibilities

• Manage all aspects of implementing Site Contracts for assigned studies, including Non-Disclosure Agreements (NDAs), Clinical Trial Agreements (CTAs), contract amendments, and associated documents.
• Ensure Site Contracts meet consistent standards and comply with local legal requirements for assigned studies.
• Oversee initiation and completion steps for Site Contracts in parallel with study start-up timelines and site initiation projections.
• Serve as liaison with the client by reporting on the status and execution of all related contract documents.
• Negotiate the terms of all Site Contract templates with each Sponsor at the beginning of each project.
• Coordinate between Sponsors and country experts during contract negotiations.
• Support quality by reviewing and advising on requested language and budget changes from investigator sites; liaise with the Sponsor and negotiate solutions with country experts.
• Establish and tailor templates for new studies by selecting appropriate templates and tailoring them to study requirements; confirm suitability with Sponsors and, when necessary, with local country experts.
• Work with Regulatory Submission Managers to provide final CTA and/or budget per country/site as needed for country regulatory submissions.
• Independently communicate on contract-related items with Regulatory Submission Managers as needed per study.
• Escalate legal questions/issues appropriately to the Line Manager, Legal Counsel, or Sponsor.
• Proactively identify site contract and budget risks, potential controversies, and conflicts; propose solutions to resolve or mitigate issues.
• Participate in internal and external project-related meetings as needed.
• Assist in development and implementation of new initiatives and processes related to site contracts.
• Interact with clients and other functional areas as a secondary project contact for contracting issues and questions.
• Collaborate with internal study team members (including start-up teams and Clinical Lead) to achieve client deliverables and expectations.
• Serve as the liaison between country-level experts and the client for CTAs/NDAs for assigned studies.
• Represent the Contracts Department in internal and Sponsor kick-off meetings.
• Establish study contract negotiation timelines at the beginning of each study and oversee site contract milestones, deliverables, and deadlines throughout the study.
• Liaise with internal customers to review contract and budget areas impacting final execution of site contracts.
• Guide Site Contract negotiators to successful completion of study timelines and deadlines.
• Ensure contractual agreements among the organization, clinical investigators, institutions, and clients are clear, fair, and legally binding.
• Review and advise on Regulatory and Clinical Operations SOPs, WGs, and ADs related to NDAs, CTAs, investigator grants, and Letters of Authorization or Powers of Attorney.
• Provide training on clinical site contractual requirements and negotiation.
• Mentor and train junior staff.
• Perform other activities as designated.

Requirements

• Experience negotiating and managing clinical site contract documentation, including NDAs, CTAs, contract amendments, and associated materials.
• Knowledge of ensuring contracts comply with local legal requirements and consistent documentation standards.
• Ability to manage contract timelines in parallel with study start-up and site initiation projections.
• Strong communication and stakeholder management skills with clients, country experts, and internal teams.
• Ability to review and advise on contract and budget changes requested by investigator sites.
• Demonstrated ability to identify contract and budget risks, resolve issues, and escalate legal questions appropriately.

Preferred Qualifications

• Familiarity with training delivery and mentoring/leadership of junior staff.
• Experience supporting regulatory submission needs related to finalized CTAs and/or budgets per country/site.

Compensation & Benefits

• Not specified.

Location

• Not specified.