Clinical Contracts Manager

About the role

We are seeking a highly skilled Clinical Contracts Manager to oversee the identification and selection of Clinical Development vendors, including Contract Research Organizations (CROs), central labs, imaging vendors, and other specialty service providers. The successful candidate will manage the documentation and processes necessary to select the optimal contract service provider, ensuring efficient and compliant execution of contractual documents.

Responsibilities

• Identify and select Clinical Development vendors, including CROs, central labs, and imaging vendors.
• Manage documents and processes for selecting contract service providers, including RFI/RFP development, bid grid analysis, and stakeholder recommendations.
• Negotiate contract business terms, scopes of work, master service agreements, pricing, and payment schedules within approved parameters.
• Assist Clinical Development teams in defining, reviewing, validating, and negotiating vendor change orders and amendments.
• Collaborate with Finance and Legal to provide insights into incremental costs and highlight contractual issues.
• Monitor vendor performance against contractual KPIs/SLAs and maintain oversight documentation.
• Participate in vendor governance meetings and manage day-to-day vendor relationships.
• Support Finance/Accounting with general contracting queries, payment schedule interpretation, and contract burn management.
• Build and validate per-patient and per-site budget models using fair market value industry benchmarking data.
• Review, negotiate, escalate, and maintain clinical trial site budgets and investigator grants across assigned studies.

Requirements

• Minimum 5 years of site budget and outsourcing experience in the biotech or pharmaceutical industry.
• Demonstrated experience in developing, negotiating, and managing clinical trial site budgets.
• Experience with CRO and vendor contract negotiation and financial management.
• Working knowledge of Good Clinical Practice (GCP), FDA regulations, and ICH guidelines.
• Working knowledge of Medicare Coverage Analyses and CMS National Coverage Determinations.
• Advanced proficiency in embedding AI as a tool into workflows and projects.

Qualifications

• Bachelor of Science or Bachelor of Arts degree.
• Experience with oncology trials, including cell therapy, CAR T, or other complex trials.
• Direct clinical site experience and navigating ex-US sites from a sponsor perspective is a plus.
• Ex-US experience is beneficial.
• Prior leadership and managerial experience in clinical outsourcing.

Work Environment

The work environment involves collaboration with Clinical Operations to facilitate interactions with CROs and clinical sites. The role requires adherence to industry standards and regulations, and the ability to negotiate and manage complex budgets and contracts effectively.

Pay

• $96.00 - $96.00/hr

Schedule

This is a Contract position based out of Seattle, WA. This is a hybrid position in Seattle, WA.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)