Contract Specialist - FSP

IQVIADurham, NC
21h

About The Position

The Contract Specialist play an important role in driving the costings and contracts being responsible for negotiation and budgeting in clinical trials and for developing and managing contracts and annexes with investigators and institutions or external vendors ensuring ethical, fair and compliant practices.

Requirements

  • Bachelor's degree
  • Excellent knowledge of international guidelines ICH-GSP, basis knowledge of GMP/GDP
  • Excellent attention to details, good written and verbal communication skills, collaboration and interpersonal skills, negotiation skills

Responsibilities

  • Adapt global templates of agreements to local use in accordance with local requirements and SOPs.
  • Develop and negotiate clinical site budgets based on Fair Market Value.
  • Negotiate agreement language and budget with clinical study sites.
  • Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.
  • For reach agreement maintain the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources
  • Ensure final contract documents are consistent with agreements reached at negotiations
  • Ensure all agreements are executes in a timely manner contributing to efficient site start-up timelines
  • Support internal and external audit activities
  • Ensure all contracts are included in the TMF
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