Company
Biotech
InvestigatorContractsLead-FSP
Neural analysis suggests this role is
optimal for Lead candidates.
“Investigator Contracts Lead - FSP. Skills: Clinical trial contracting, Budget negotiation, Stakeholder management. Lead site contracting activities for clinical studies. Lead budget negotiation activities for clinical studies”
Industry & Context.
Risk management
What They're Looking For.
Must Have
Bachelor’s degree or equivalent experience, 5+ years of experience in clinical development operations, clinical trial outsourcing, or site contracting, Knowledge of clinical trial agreements, budgeting principles, and negotiation processes, Experience working with clinical trial sites and managing contract negotiations, Solid understanding of ICH-GCP guidelines and clinical research compliance requirements, Analytical mindset with the ability to manage risks, Fluency in written and spoken English
Nice to Have
Experience in a global environment, Experience in complex, matrixed organizations
What You'll Do.
Lead site contracting activities for clinical studies
Lead budget negotiation activities for clinical studies
Ensure timely execution of Clinical Trial Agreements
Ensure timely execution of amendments
Manage Per-Subject Cost (PSC) processes
Oversee global site budget development
Collaborate with internal stakeholders on budget development
Serve as primary point of contact for site
Serve as primary point of contact for escalations
Serve as primary point of contact for timeline
Negotiate contractual terms with clinical trial sites
Negotiate financial terms with clinical trial sites
Negotiate business terms with clinical trial sites
Partner with Legal to resolve escalations
Partner with Finance to resolve escalations
Partner with pCROs to resolve escalations
Partner with clinical operations teams to resolve escalations
Partner with Legal to improve contracting processes
Partner with Finance to improve contracting processes
Partner with pCROs to improve contracting processes
Partner with clinical operations teams to improve contracting
Coordinate with cross-functional teams
Align contracting timelines with study start-up objectives
Lead other contracting professionals
Support other contracting professionals
Ensure consistency across deliverables
Ensure quality across deliverables
How You'll Work.
Team & Collaboration
Cross-functional teams; Internal stakeholders; Legal; Finance; PCROs; Clinical operations teams
Communication Scope
Negotiation
Process & Methodology
Timeline management
Full Job Description
## Accountabilities Lead site contracting and budget negotiation activities for assigned clinical studies, ensuring timely execution of Clinical Trial Agreements and amendments. Manage and oversee Per-Subject Cost (PSC) processes and global site budget development in collaboration with internal stakeholders. Serve as the primary point of contact for site contracting issues, escalations, and timeline management across assigned studies. Negotiate contractual, financial, and business terms with clinical trial sites within approved legal and compliance frameworks. Partner with Legal, Finance, pCROs, and clinical operations teams to resolve escalations and improve contracting processes. Coordinate with cross-functional teams to align contracting timelines with study start-up objectives. Lead and support other contracting professionals when applicable, ensuring consistency and quality across deliverables. Requirements: Bachelor’s degree or equivalent experience in life sciences, business, or related field. 5+ years of experience in clinical development operations, clinical trial outsourcing, or site contracting. Strong knowledge of clinical trial agreements, budgeting principles, and negotiation processes in a global environment. Experience working with clinical trial sites and managing contract negotiations in complex, matrixed organizations. Solid understanding of ICH-GCP guidelines and clinical research compliance requirements. Strong communication, negotiation, and stakeholder management skills, with the ability to influence without direct authority. Fluency in written and spoken English is required. Analytical mindset with the ability to manage risks and ensure delivery against tight clinical timelines. Benefits: Competitive compensation package aligned with clinical operations expertise Opportunity to work in a global clinical research environment Exposure to international studies and cross-functional project teams Career development within clinical operations and c
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