Senior Contract Manager, Clinical Site Budgets and Outsourcing

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.

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.

Requirements

• Bachelor of Science or Bachelor of Arts
• Minimum 5 years of site budget and outsourcing experience in the biotech or pharmaceutical industry
• Demonstrated experience developing, negotiating, and managing clinical trial site budgets; direct clinical site experience and navigating ex-US sites from a sponsor perspective 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; experience with oncology trials, including cell therapy, CAR-T, or other complex trial experience is preferred
• Working knowledge of Good Clinical Practice (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, National Comprehensive Cancer Network (NCCN) Guidelines, and application to support and influence budget negotiations
• Applicants must be authorized to work in the United States.

Additional Details

• Location model: Hybrid (3 days onsite and 2 days remote)
• Position Type: 6-month contract with potential for extension / conversion
• Pay range approved: $85 - 96/hr depending on experience

For workers in the United States, PrideGlobal and it's affiliates offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, pet insurance and employee discounts with preferred vendors.

Equal Employment Opportunity

PrideGlobal and it's affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.

Fair Chance Employment

PrideGlobal and it's affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.

Accommodations

We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.

Only applicable for San Francisco Candidates

Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.

Only applicable for Kentucky positions

For this type of employment, state law requires a criminal record check as a condition of employment. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793.