Investigator Contracts Lead - FSP
United States of America, Remote Additional Locations: Remote - United States of America Job ID R0000027183 Category Clinical TrialsAbout this Role
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.
- 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, CRO 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
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
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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