Investigator Contracts Lead - FSP

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

• Key Accountabilities

  Contracting deliverables

  • Exercise good judgment in balancing the risks to the client in making budget and contractual decisions against the impacts to client clinical trial timelines

  • Follow client processes to develop, negotiate, track 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 • Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters

  • Lead study level site contracting activities, direct other ICL and act as primary study point of contract 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 • Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space

  • Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline

  Collaboration

  • Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface
  • Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements
  • Interacts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, CRO site contracting teams
  • Contributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to achievement of client business objectives

  Skills
  • 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 English is required

  Knowledge and Experience
  • Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities
  • Knowledge of the principles, concepts and theories in applicable business discipline
  • Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferred

  Education
  • Bachelor’s Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR
  • Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing