Site Contracts Manager

Advanced Recruiting Partners; Raleigh (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

A clinical research organization in Raleigh, NC is seeking a Contract Manager to lead negotiations for clinical study contracts, ensuring compliance and effective collaboration with various stakeholders. The ideal candidate should have experience in contract negotiation, familiarity with GCP guidelines, and the ability to manage vendor performance effectively. This role involves improving business processes and maintaining contract templates, contributing to successful study outcomes.

Qualifications

• Experience in negotiating clinical study contracts and budgets.
• Ability to collaborate with cross-functional teams.
• Familiarity with regulatory compliance and Good Clinical Practice (GCP) guidelines.

Responsibilities

• Lead negotiations for clinical study contracts and agreements.
• Collaborate with stakeholders to align contract terms and conditions.
• Manage contract execution and compliance with internal procedures.
• Track performance of vendors and investigators in studies.
• Identify opportunities for process improvements in contract management.

Skills

Contract negotiation

Collaboration

Compliance with regulations

Project management

Attention to detail

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.