Clinical Contract Negotiator

7 days ago


Cambridge, Massachusetts, United States Integrated Resources, Inc ( IRI ) Full time

We are seeking a skilled Clinical Contract Manager to join our team at Integrated Resources, Inc (IRI) in Cambridge, MA.

About the Role

This is a global R&D level position focusing on supporting the Global Clinical Development Operations (CDO) function as part of the CDO Business Strategy & Operations group. The successful candidate will manage and facilitate the management of clinical trial/clinical project related contracts as per guidance of the legal department and other applicable Company policies and procedures.

Responsibilities
  • The individual will have a paralegal background and experience with review and feedback on requests for changes to company defined standard T&C sections of master or country specific clinical trial agreements.
  • This includes but is not limited to preparing/reviewing and negotiating standard terms and conditions language and requests for changes to such language by clinical sites in clinical trial agreements and related contracts for all R&D studies worldwide.
  • The Clinical Contract Manager works closely with the CDO project teams, R&D Service Providers, clinical sites, and other R&D functional leaders across Clinical Operations, Legal, Finance, Corporate Compliance to ensure appropriate contracts are in place for each of the clinical trials and clinical operations projects.
  • Draft, evaluate, negotiate, execute & archive Clinical trial/ Clinical project related contracts.

The ideal candidate should be comfortable in bridges between clinical operations teams, site contracting teams and legal teams. They must be process oriented, strong on process enhancement and control needs, rigorous and organized.

Requirements
  • 5+ years of post-qualification experience, including relevant international experience in clinical trials contract management.
  • Experienced in reviewing standard terms and conditions and legally approved standard clauses within the company's contract templates and the variations in such clauses as may be needed to address country specific requirements (Global).
  • Experienced in negotiating with trial sites' and service providers' legal and / or contracting teams across international locations.
  • Experience working with R&D teams and cross-functional teams.
  • Demonstrated ability to juggle multiple contract / tasks demands at one time whilst remaining responsive to internal clients' requests.

We estimate the salary range for this role to be $80,000 - $110,000 per year, depending on qualifications and experience.



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