Senior Contract Manager

3 weeks ago

Darwin, Northern Territory, Australia Pharmiweb Full time
Senior Study Contract Manager

Parexel FSP is seeking a highly skilled Senior Study Contract Manager to join our team on a permanent full-time, home-based basis. The position can be based in the Netherlands or Belgium.

We are dedicated to a single sponsor in BioPharma, who is revolutionizing healthcare by harnessing the power of science to benefit people, society, and the planet. Our science-driven approach aims to transform healthcare and improve patient outcomes, while also fulfilling a purpose-led role in society.

Key Responsibilities
  • Adapt global templates of agreements to local use by 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 the integrity of contracts.
  • Maintain the status of agreements, 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 executed promptly contributing to efficient site start-up timelines.
  • Support internal and external audit activities.
  • Ensure compliance with client's Code of Conduct and company policies and procedures relating to people, finance, technology, and security.
  • Ensure that all contracts are included in the Trial Master File (TMF).
Requirements
  • At least 2 years of experience in site contract negotiation/customization.
  • Experience in negotiating contracts with clinical investigative sites/hospitals.
  • Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
  • Good knowledge of relevant local regulations.
  • Basic understanding of the drug development process.
  • Good understanding of Clinical Study Management including monitoring, study drug handling, and data management.
  • Experience of Netherlands contracts.
  • Desirable - experience with Belgium contracts.
Education

Bachelor's degree in a related discipline, preferably in life science, law, finance, or equivalent qualification.

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