Job Description

Clinical Site Lead with contracting experience (ID 1937)

- Pharmaceuticals Employee
Posted by Fanny Steylemans on 16/03/2021

Is contract and budget negotiation and follow-up your passion and do you like to work in an international environment? Then we have a great opportunity for you as Clinical Site Lead within a global biopharmaceutical company.  Contracting from A-Z experience is a must!


Objectives/Purpose of the job

Responsible for the end-to-end management of budgeting and contracting for Study Teams with a focus on contracting a variety of contracts & study types including Confidential Disclosure Agreements (CDAs), Investigator contracts, non-registrational / Investigator Sponsored Research (ISR) studies.


Key Responsibilities

  • Provide knowledgeable single-point of service to study teams related to study budgets and contracts
  • Prepare study /site level grant budgets
  • Manage the end-to-end process for executing Clinical Trial Agreements (CTAgs) with investigator sites
  • Prepares contract documents from templates and modify to reflect unique aspects of the particular study, including the CTAg financial appendix,
  • Negotiates financial and legal aspects of CTAg and Master Service Agreements with sites, Institutions or vendor personnel
  • Is trained on legal fall back language and works with Legal as needed.
  • Communicates clearly and efficiently with Clinical and Legal Teams regarding amendments and other issues
  • Enter CTAg documents and data into Clinical Trial Management System and contract management software and ensure correct filing.
  • Preparation, negotiation and execution of Master Agreements with Institution
  • Develop and maintain template language in collaboration with legal for all contract types.  Would include maintenance of associated back-up language
  • Escalate to appropriate colleague when a significant risk to the business is identified
  • Independently make appropriate business decisions within their scope or authority, and educate internal project leaders on the issues and risks associated with contracting decisions
  • Ensure contracts are executed in alignment with trial deliverables and priorities
  • Execute local purchase contracts if applicable (e.g. of drug, equipment)
  • Ensure all CTAgs and payments are accurately posted and ensure correct filing
  • May support preparing invoices/payments due reports and managing, tracking and executing payments to investigator sites


Requirements/Qualifications of successful candidate

  • Good verbal and written communication skills (both in English and Dutch)
  • A proven track record (min. 3 years) in a similar position
  • Possess strong organization and time management skills and ability to effectively manage multiple competing priorities
  • Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels
  • Strong negotiation and interpersonal skills including strong conflict resolution skills
  • Excellent computer and internet skills :
    • Microsoft Suite
    • Clinical Trial Management Systems (CTMS)
    • SAP
    • Contract management software

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