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

Parexel

🌍 Remote

Posted 1 months ago

Quick Info

Job Type

Full Time

Specialty Skills

clinical study agreementssite contractingbudget negotiationcontract negotiationdrug developmentrisk mitigation

About the Role

About this Role 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