The Investigator Contracts Lead is responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies. This also includes managing the Per-Subject Cost (PSC) process for assigned studies, managing escalation and resolution for budget and non-legal term issues from other ICL or preferred Contract Research Organizations and collaborating with other lines to plan site contracting timelines though start up.
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
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
- Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing
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