Specialist, Contract Management Pharmaceutical Development

Added
25 days ago
Type
Full time
Salary
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Related skills

gcp contract management clinical research site management legal compliance

📋 Description

  • Serve as point person of site contracts for Legal, Finance, Site Management & Monitoring and
  • Accountable for timely Preparation and Execution of CDAs, CSAs and Budgets, other site agreements
  • Direct negotiation of CDAs, CSAs and Budgets and other site agreements with investigator sites
  • Liaising with Legal where Playbook doesn’t already address an issue and seeking Legal approval for
  • Setting, managing and communicating priorities on site level to local affiliate stakeholders
  • Contribute site-level input to the continual update of Playbooks and Templates in collaboration

🎯 Requirements

  • Appropriate tertiary qualification, health related (Medical, Scientific, Nursing) preferred.
  • Minimum three years clinical research experience including contract/budget negotiation.
  • Proven negotiating skills, tact and diplomacy.
  • 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
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