Investigator Contracts Lead

2 days ago

Canberra, Australia Parexel Full time

External Job Description

**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

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

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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