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Investigator Contracts Lead
2 months ago
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 timelinesFollow client processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trialsWork with partners to develop and oversee the global site budget processWork 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 parametersLead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studiesPartner with Legal and other divisions to manage escalations in the site budgeting and contracting spacePartner with Legal, Finance, CRO and other divisions to identify and implement areas of improvement in the site contracting spaceApplies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable disciplineKnowledge and Experience:Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activitiesKnowledge of the principles, concepts and theories in applicable business disciplineExperience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferredEducation:Bachelor's Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcingJuris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing#LI-REMOTE
