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.

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.