Sr. Manager, Investigator Site Budgets & Contracts
Core
Lead the development and oversight of investigator site budgets and contract strategy for global clinical trials, partnering with Clinical Operations, CROs, and Legal to accelerate study start-up.
Role type
Senior Manager, Clinical Trial Budgets & Contracts
Builds
Global clinical trial budgets, Clinical Trial Agreements (CTAs), and financial forecasts for Phase I-IV studies.
Domain
Biopharma / Clinical Research / Contract Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global investigator site budget creation and negotiation, Fair Market Value (FMV) methodologies, Clinical Trial Agreement (CTA) negotiation, scenario planning, financial analysis, process improvement, stakeholder management, data validation, risk identification
Preferred skills
CTA template language negotiation, outsourced clinical development model experience, Generative AI tool usage
Technologies
Grants Manager, GrantPlan, Microsoft Excel
Responsibilities
Lead creation and oversight of investigator site budgets for multiple global clinical trials; Generate and review accurate Phase I-IV investigator grant budgets; Support scenario planning by evaluating budget assumptions; Validate investigator grant budgets using internal and third-party data; Provide strategic site budget and contract guidance to Clinical Operations teams; Lead and contribute to development of FMV-based investigator grant budgets and negotiation parameters; Serve as primary point of contact for CRO site budget activities; Oversee development and consistency of global investigator site budgets; Directly manage and track CRO investigator site CTA and budget negotiations; Act as liaison between CROs and Legal/Contracts teams; Monitor KPIs including negotiation cycle times and site activation targets; Lead site contract and budget amendment activities; Proactively identify site contract risks and operational roadblocks; Support development of departmental processes and SOPs
Seniority
Senior Manager, hands-on IC with strategic oversight