Investigator Contracts Lead – Contracts & Budgets Analyst

Responsibilities

• Responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments
• Manage the Per-Subject Cost (PSC) process for assigned studies
• Manage escalation and resolution for budget and non-legal term issues from other ICL or preferred Contract Research Organizations (pCRO)
• Collaborate with other lines to plan site contracting timelines through startup
• 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
• 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, and CRO site contracting teams
• Contributes to design, development and implementation of major business initiatives or special projects where required

Requirements

• Bachelor’s Degree or equivalent
• 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
• 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
• Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities
• Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation is preferred

Core Competencies

Demonstrates expertise in clinical trial budgeting and contracting, with a strong focus on negotiation, risk management, and collaboration across multiple stakeholders. Proficient in developing and executing global clinical study agreements while ensuring compliance and alignment with financial and legal standards.