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Clinical Contracts Associate / Senior Clinical Contracts Associate (Job Code: 8HR149)

The Clinical Contracts Associate / Senior Clinical Contracts Associate's primary responsibilities shall include but are not limited to the preparation, negotiation, tracking and finalization of the clinical trial agreements and confidentiality agreements inclusive of the site budget within the clinical trial agreement.

This position reports to the Associate Director, Clinical Contracts and Outsourcing.

Specific duties

  • Draft and track status of clinical trial agreements, amendments and confidentiality agreements with site specific information and e-mail to sites
  • Status the sites regarding outstanding agreements and budgets, and provide weekly updates to clinical team
  • Process all agreements for execution, ensuring that the appropriate departments within FibroGen receive a copy
  • Ensure that all budget approvals, correspondence, invoices and fully executed contracts are filed within the clinical contracts filing system and ensure files are audit ready
  • Track all fully executed clinical agreements and invoices
  • Update the financial spreadsheets for each study/site
  • Liaise with clinical for monthly site accruals
  • Pay and track all payments to investigator sites
  • Responsible for the development of site budget templates
  • Negotiate directly with the sites regarding budgets and contract language
  • Liaise with legal for review of contract language
  • Mentor Clinical Contract Associates and may have a supervisory role (Senior Clinical Contracts Associate)

    Requirements

  • BS/BA in Business Administration, finance or related discipline, or equivalent education plus experience
  • Minimum of 5-7 years of experience in a contract administration environment in a pharmaceutical or biotech company (Senior Clinical Contracts Associate) and Minimum of 2 years of experience in a contract administration environment in a pharmaceutical or biotech company (Clinical Contracts Associate)
  • Broad knowledge of general pharmaceutical contract law, regulatory law and policies relevant to clinical contracts
  • Excellent negotiation and written/verbal communication skills
  • Ability to work independently, creative thinking and problem solving skills
  • Must have good organization and planning skills, proven ability to handle multiple priorities and work independently
  • Must be a team player and be a leader within the department
  • Proficiency with MS Word, Excel, Access and Outlook required

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    FibroGen 2008 (C)