P
Investigator Contracts Lead I- FSP (Dedicated to client office)
Parexel🌍 Remote
Posted 1 months ago
Quick Info
Job Type
Full TimeSpecialty 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