Investigator Contracts Lead I- FSP (Dedicated to client office)
Parexel
Key Accountabilities:
Contracting Deliverables
Exercise sound judgment in balancing client risk with clinical trial timeline impacts when making budget and contractual decisionsFollow client-specific processes to develop, negotiate, track, and execute global clinical study agreements with institutions and investigatorsCollaborate with internal and external partners to develop and oversee the global site budget processNegotiate directly with clinical trial sites on cost, business, and contractual terms, making template adjustments within Legal-approved parametersLead study-level site contracting activities, guide other contract leads, and serve as the primary contact for site contracting issues and timelines on assigned studiesPartner with Legal and other departments to manage escalations related to site budgeting and contractingWork with Legal, Finance, pCRO, and other stakeholders to identify and implement improvements in the site contracting processApply acquired job skills and procedures to complete assignments and projects of moderate scope and complexityCollaboration
Build and maintain relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interfaceCollaborate with invoicing specialists and service providers to ensure alignment with site contracting and compensation requirementsInterface with site legal contacts, client legal teams, study management, site payments teams, peer contracting colleagues, and CRO contracting teamsContribute to the design, development, and implementation of major business initiatives or special projects, applying technical expertise to support client objectivesSkills and Competencies
Strong balance of business, compliance, finance, legal, and drug development knowledgeClear and precise communication and presentation skillsAbility to plan, identify, and mitigate risks to site contracting timelinesCapable of leading through influence rather than authority to achieve key deliverablesProven success in a highly matrixed organizational environmentFluency in written and spoken English is requiredKnowledge and Experience
Experience with clinical study budgets and contract negotiation principles, practices, and processesUnderstanding of core concepts and theories in relevant business disciplinesPreferred experience in drafting and negotiating Clinical Trial Agreements with global clinical trial sitesEducation
Bachelor’s degree or equivalent with 5+ years of experience in clinical development operations or clinical trial outsourcingORJuris Doctorate or equivalent with 2+ years of experience in clinical development operations or clinical trial outsourcing
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