Investigator Contracts Lead - FSP (Site Contracts Lead)

Parexel • Remote (Australia) • 1d ago

Key Accountabilities:

Contracting deliverables

Exercise good judgment in balancing the risks to the client in making budget and contractual decisions against the impacts to client clinical trial timelines

Follow client processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials

Work with partners to develop and oversee the global site budget process

Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters

Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies

Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space

Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space

Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline

Collaboration

Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface

Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements

Interacts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, CRO site contracting teams

Contributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to achievement of client business objectives

Compliance with Parexel standards

Complies with required training curriculum

Completes timesheets accurately as required

Submits expense reports as required

Updates CV as required

Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

Balance of general business, compliance, finance, legal, and drug development experience

Precise communications and presentation skills

Ability to plan, identify and mitigate risks to site contacting timelines

Ability to lead by influence rather than positional power to accomplish critical deliverables

Success in working in a highly matrix based organization

Fluency in written and spoken English is required

Knowledge and Experience:

Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities

Knowledge of the principles, concepts and theories in applicable business discipline

Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferred

Education:

Bachelor’s Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR

Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing

#LI-REMOTE

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