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Clinical Contracts Specialist

Il y a 2 mois


Paris, Île-de-France Parexel Temps plein

About the Role:

Parexel FSP is seeking a highly skilled Clinical Contracts Specialist to join our team in France. As an Investigator Contracts Lead, you will play a critical role in negotiating and managing contracts with clinical investigator sites, ensuring seamless execution of clinical trials.

Key Responsibilities:

  • Develop and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials.
  • Work with partners to develop and oversee the global site budget process, ensuring accurate and timely financial management.
  • Negotiate cost, business, and contractual terms and conditions with investigators/institutions, making changes to contract templates within approved parameters.
  • Lead study-level site contracting activities and act as primary study point of contact for site contracting issues and timelines on assigned studies.
  • Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space.
  • Collaborate with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements.
  • Interact with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, and CRO site contracting teams.

Requirements:

  • Balance of general business, compliance, finance, legal, and drug development experience.
  • Precise communications and presentation skills.
  • Ability to plan, identify, and mitigate risks to site contacting timelines.
  • Ability to lead by influence rather than positional power to accomplish critical deliverables.
  • Success in working in a highly matrix-based organization.
  • Fluency in written and spoken French is required.
  • Advanced level of English, written and spoken.
  • Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities.
  • Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation is preferred.

Education:

  • Bachelor's Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR PhD/Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing.