Oversee CRO execution of investigator site budgets, contracts, site payments, and ICF deliverables.
Coordinate clinical trial insurance needs and support Sunshine Act/transparency reporting requirements.
Ensure operational consistency, manage escalations, and contribute to compliance, quality, and governance activities.
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.
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.
Collect, validate, and reconcile transparency-related data.
Partner with Compliance to ensure accurate, timely reporting.
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.

Senior Manager, Clinical Trial Business Operations

Key skills