Clinical Outsourcing Manager

Clinical Outsourcing Manager (Contract)

I'm partnering with a growing biotechnology company seeking a Clinical Outsourcing Manager to support clinical development programs through vendor management, contract negotiations, and clinical trial site budget oversight.

Requirements

• Bachelor's degree in Life Sciences, Business, Finance, or related field

• 5+ years of experience in clinical outsourcing and clinical trial site budgets within the biotech or pharmaceutical industry

• Strong experience developing, negotiating, and managing clinical trial site budgets and investigator grants

• Experience with CRO and vendor selection, contract negotiations, scopes of work, pricing, and change orders

• Strong financial and analytical skills, including FMV benchmarking, budget forecasting, and spend tracking

• Working knowledge of GCP, FDA regulations, and ICH guidelines

• Advanced proficiency with Excel; Smartsheet experience preferred

Responsibilities

• Lead CRO and clinical vendor selection, including RFPs, bid analysis, and vendor recommendations

• Negotiate vendor contracts, pricing, payment schedules, scopes of work, and amendments

• Manage vendor performance, governance meetings, and ongoing vendor relationships

• Develop, review, and negotiate clinical trial site budgets and investigator grants

• Build budget models using protocol requirements, FMV data, and internal benchmarks

• Review Medicare Coverage Analysis and resolve site billing and budget questions

• Track site and vendor spend against forecasts and identify budget variances

• Partner with Clinical Operations, Finance, Legal, and external CROs to ensure projects remain on budget and on schedule

Preferred

• Oncology clinical trial experience

• Cell therapy, CAR-T, or other complex clinical trial experience

• Experience with ex-US/global clinical sites

• Prior leadership experience in clinical outsourcing

• Knowledge of Medicare Coverage Analysis, CMS guidelines, and NCCN Guidelines

• Experience using AI tools such as Claude to improve workflows and scalability

Location: Hybrid – South San Francisco, CA or Seattle, WA

Duration: 6-Month Contract

Interviews are starting soon, so if you're interested and would like to be considered, give me a call at (919) 892-9841 as soon as you're available.