Job Summary
The role entails overseeing the global budget strategy for investigator sites, particularly within oncology studies. This includes the development, benchmarking, and negotiation of budgets, as well as the execution of Clinical Trial Agreements (CTAs) and Fair Market Value (FMV) documentation. The position also involves collaboration with internal teams and vendors to enhance site activation efficiency while maintaining compliance standards.
Responsibilities
- Lead the strategy and development of global investigator site budgets.
- Benchmark and negotiate budgets for oncology clinical studies.
- Oversee the execution of Clinical Trial Agreements (CTAs) and manage Fair Market Value (FMV) documentation.
- Coordinate activities with internal teams and external vendors.
- Manage start-up performance monitoring and risk assessment.
- Enhance processes to expedite site activation while ensuring adherence to compliance.
Qualifications
- At least 10 years of experience in a relevant field with a bachelor’s degree, or a minimum of 8 years with a postgraduate degree.
- Demonstrated expertise in clinical operations, study start-up, or investigator site budgeting.
- Proficient in protocol-based budgeting practices and Fair Market Value principles.
- Experience in clinical trial start-up and project management.
- Familiarity with Veeva Vault Clinical is advantageous.
- Oncology-related experience and relevant certifications are preferred.
