Investigator Contracts Lead, Contracts & Budgets Analyst

Role Overview

• The Investigator Contracts Lead (ICL) 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 (pCRO) and collaborating with other lines to plan site contracting timelines though start up.
• Exercise good judgment in balancing the risks to the sponsor in making budget and contractual decisions against the impacts to client clinical trial timelines.
• Follow 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 and act as primary study point of contact 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.
• Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface.

Requirements

• Bachelor’s Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR PhD/Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing
• Balance of general business, compliance, finance, legal, and drug development experience
• Precise communications and presentation skills
• Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities
• Fluency in written and spoken English is required.

Benefits

• flexible work arrangements