Senior Clinical Site Budget & Outsourcing Lead

Russell Tobin; Seattle (WA); Hybrid; USD 80,000 - 132,000; Full time

Job summary

Russell Tobin is partnering with an exciting biotechnology company to identify a Senior Contract Manager, Clinical Site Budgets and Outsourcing for an opportunity near Seattle, WA. Lead selection and management of Clinical Development vendors, develop RFI/RFPs, negotiate contracts, and monitor performance.

Build site budgets with CROs and sites, and drive forecasting with MSAs, SOWs, and cost models. Ideal candidate has 5+ years in site budget/out outsourcing, GCP/FDA knowledge, and US work

Qualifications

• Minimum 5 years of site budget and outsourcing experience in biotech/pharma.
• Experience developing, negotiating, and managing clinical trial site budgets; sponsor perspective for ex-US sites is a plus.
• Experience with CRO and vendor contract negotiation and financial management, including validating CRO investigator grant assumptions; ex-US experience is a plus.
• Prior leadership and managerial experience in clinical outsourcing; oncology trials, including cell therapy/CAR-T or other complex trial experience, preferred.
• Working knowledge of GCP, FDA regulations, and ICH guidelines as they relate to sponsor clinical trial conduct and sponsor vendor oversight.
• Working knowledge of Medicare Coverage Analyses, CMS National Coverage Determinations, NCCN Guidelines, and application to support and influence budget negotiations.
• Applicants must be authorized to work in the United States.

Responsibilities

• Lead selection and management of Clinical Development vendors, including CROs, central labs, imaging vendors, and specialty providers.
• Develop and manage RFI/RFP processes, bid analyses, vendor evaluations, and stakeholder recommendations.
• Negotiate vendor contracts, SOWs, MSAs, pricing, payment terms, amendments, and change orders.
• Monitor vendor performance against KPIs/SLAs and maintain oversight documentation for inspection readiness.
• Manage vendor governance meetings and day-to-day relationships with internal and external stakeholders.
• Develop and validate clinical trial site budgets, investigator grants, and per-patient/per-site cost models.
• Negotiate and maintain site budgets in partnership with Clinical Operations, CROs, and clinical sites.
• Track site and vendor spend, identify variances, and drive forecasting and reforecasting activities.
• Maintain and improve budget templates, trackers, cost assumptions, and financial tools using Excel/Smartsheet.

Skills

Vendor management

Contract negotiation

Budget forecasting

Leadership/management

Clinical trial budgeting

Education

BS/BA

Tools

Excel

Smartsheet

Job description

Russell Tobin is partnering with an exciting biotechnology company to identify a Senior Contract Manager, Clinical Site Budgets and Outsourcing for an opportunity near Seattle, WA. Lead selection and management of Clinical Development vendors, develop RFI/RFPs, negotiate contracts, and monitor performance.

Build site budgets with CROs and sites, and drive forecasting with MSAs, SOWs, and cost models. Ideal candidate has 5+ years in site budget/out outsourcing, GCP/FDA knowledge, and US work