Investigator Contracts Lead I- FSP (Dedicated to client office)

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