Senior Manager, Clinical Trial Business Operations

Reports to: Associate Director, Clinical Trial Business Operations

Position Summary

The Senior Manager, Clinical Trial Business Operations (CTBO) oversees CRO execution of investigator site budgets, contracts, site payments, and ICF deliverables. This role is also responsible for coordinating clinical trial insurance needs and supporting Sunshine Act/transparency reporting requirements. The Senior Manager ensures operational consistency, manages escalations, and contributes to compliance, quality, and governance activities.
Key Responsibilities
CRO Oversight

• Review and oversee CRO work related to budgets, contracts, payments, and ICFs.
  
• Ensure accuracy, quality, and alignment with internal templates, processes, and parameters.
  
• Provide operational guidance to CRO teams to ensure consistency across regions and studies.

• Manage escalations exceeding CRO negotiation authority.
  
• Partner with Clinical Operations, Finance, Legal, and other teams to resolve issues efficiently.
  
• Document and communicate decisions to support timely study startup.
  

• Intake and triage insurance requests and required inputs.
  
• Work with Global Insurance & Risk Management to ensure appropriate coverage.
  
• Track insurance progress and address issues affecting study activation.
  

• Collect, validate, and reconcile transparency-related data.
  
• Partner with Compliance to ensure accurate, timely reporting.
  
• Support audit readiness for transparency-reporting activities.
  

• Apply and help maintain consistent ways of working with internal stakeholders and CRO partners.
  
• Maintain audit-ready records for budgets, contracts, insurance, and ICF decisions.
  
• Monitor operational KPIs and highlight risks or process-improvement opportunities.
  
• Participate in operational reviews and governance forums.
  

• Bachelor's degree in Business, Finance, Life Sciences, or related field.
  
• Minimum 7 years' experience supporting or overseeing site budgets, site contracts, and site payments within pharma/biotech or CRO environments.
  
• Experience working within outsourced/CRO operating models.
  
• Strong analytical, communication, problem-solving, and organizational skills.
  
• Ability to work cross-functionally and manage multiple priorities.
  

• Experience with ICF processes, clinical trial insurance, and transparency reporting.