Specialist, Contract Management Pharmaceutical Development

Added
27 days ago
Type
Full time
Salary
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Related skills

negotiation gcp budgeting contract management clinical research

📋 Description

  • Serve as the point person for their country/region for Legal, Finance, Site Management &amp
  • Accountable for the timely preparation and execution of CDAs, CSAs and Budgets and related vendor
  • Direct negotiation of CDAs, CSAs and Budgets with investigator sites using templates, guidance and
  • Input into legal aspects of the Informed Consents to ensure first pass acceptance or rapid
  • Liaising with Legal where playbook doesn’t already address an issue and seeking Legal approval for
  • Setting, managing and communicating priorities to local affiliate stakeholders, Legal, and Finance

🎯 Requirements

  • Appropriate tertiary qualification, health related (Medical, Scientific, Nursing) preferred.
  • Minimum three years clinical research experience including contract/budget negotiation. Proven
  • Understanding of medical and legal terminology and the application of business/financial concepts
  • Extensive knowledge related to ICH/GCP guidelines and applicable local regulations.
  • Ability to learn multiple concepts related to legal, compliance and regulatory matters in clinical
  • Good planning and organizational skills and the ability to work effectively and efficiently in a
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