Job Description

Job Description:

• Lead the negotiation of documents for clinical studies, including but not limited to clinical site agreements and budgets, indemnification letters, powers of attorney, confidential disclosure agreements, and informed consent documents.
• Collaborate with clinical study teams to identify trial-specific requirements to be reflected in site and investigator contract terms and to assess potential site and country-specific considerations.
• Work with Legal, Intellectual Property, and other internal stakeholders, as needed, to adapt standard site and investigator contract templates for each study and country.
• Partner with clinical study teams, Compliance, and other functions to establish realistic and acceptable fee ranges and budgets for site and investigator services across studies and programs.
• Develop detailed project specifications, share them with contract research organizations (CROs), and support the negotiation process with clinical sites and investigators, including providing guidance to CROs as required.
• Support and manage negotiations of clinical site and investigator contracts, including fees, budgets, and scope changes, to ensure cost-effective, timely, and successful outsourcing solutions. Lead negotiations when necessary.
• Ensure that all site and investigator contracts clearly and accurately define the responsibilities of all parties involved in the clinical study.
• Provide support to site contract management leadership on strategic and operational matters related to site contracting.
• Track, coordinate, and ensure timely execution, distribution, and filing of all clinical site and investigator contracts.
• Ensure compliance with internal standard operating procedures, as well as applicable laws, regulations, and Good Clinical Practice (GCP) guidelines, for all site contract–related processes and documents.
• Interact regularly with internal stakeholders and cross-functional partners to ensure alignment and integration of activities.
• Ensure that vendor and investigator performance is regularly evaluated and communicated to relevant stakeholders during routine reviews and debriefings.
• Identify opportunities for business process improvement and contribute to or lead initiatives that enhance efficiency and effectiveness in site contract management.
• Contribute to the development and maintenance of a global library of standard contract templates in collaboration with Legal.

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