Investigator Contracts Lead I- FSP

1 week ago

TaiwanRemote, Taiwan Parexel Full time

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 sound judgment in balancing client risk with clinical trial timeline impacts when making budget and contractual decisions
  • Follow client-specific processes to develop, negotiate, track, and execute global clinical study agreements with institutions and investigators
  • Collaborate with internal and external partners to develop and oversee the global site budget process
  • Negotiate directly with clinical trial sites on cost, business, and contractual terms, making template adjustments within Legal-approved parameters
  • Lead study-level site contracting activities, guide other contract leads, and serve as the primary contact for site contracting issues and timelines on assigned studies
  • Partner with Legal and other departments to manage escalations related to site budgeting and contracting
  • Work with Legal, Finance, pCRO, and other stakeholders to identify and implement improvements in the site contracting process
  • Apply acquired job skills and procedures to complete assignments and projects of moderate scope and complexity

Collaboration

  • Build and maintain relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface
  • Collaborate with invoicing specialists and service providers to ensure alignment with site contracting and compensation requirements
  • Interface with site legal contacts, client legal teams, study management, site payments teams, peer contracting colleagues, and CRO contracting teams
  • Contribute to the design, development, and implementation of major business initiatives or special projects, applying technical expertise to support client objectives

Skills and Competencies

  • Strong balance of business, compliance, finance, legal, and drug development knowledge
  • Clear and precise communication and presentation skills
  • Ability to plan, identify, and mitigate risks to site contracting timelines
  • Capable of leading through influence rather than authority to achieve key deliverables
  • Proven success in a highly matrixed organizational environment
  • Fluency in written and spoken English is required

Knowledge and Experience

  • Experience with clinical study budgets and contract negotiation principles, practices, and processes
  • Understanding of core concepts and theories in relevant business disciplines
  • Preferred experience in drafting and negotiating Clinical Trial Agreements with global clinical trial sites

Education

  • Bachelor's degree or equivalent with 5+ years of experience in clinical development operations or clinical trial outsourcing
    OR
  • Juris Doctorate or equivalent with 2+ years of experience in clinical development operations or clinical trial outsourcing

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