Investigator Budgets Manager (Biotechnology)

Investigator Budgets Manager

The Investigator Budgets Manager is responsible for developing and negotiating budgets for clinical trials in accordance with protocol specifications. They conduct budget negotiations with sites, create and maintain tracking systems, and oversee Investigator Budgets (IB) Process Manager roles. Additionally, they may supervise and train staff, conduct Medicare coverage analyses, and assist in CRO relationship management.

Essential Duties And Responsibilities :

• Develop clinical trial budgets according to protocol specifications.
• Independently manage clinical trial budget negotiations with sites, including those conducted through Contract Research Organizations (CROs) within service-level agreements.
• Maintain a tracking system of all clinical study agreements, issues, and communications with internal and external sources regarding contract and budget status.
• Responsible for directly interacting with USA and CAN sites and CROs in executing ongoing clinical trial budget negotiation reviews.
• Review and negotiate investigator-prepared budgets for FMV compliance.
• Develop management reports to support budgeting and forecasting.
• Contribute to the design, format, and content of CRO and site budget guides and template instructions.
• Prepare presentations for Investigator and vendor meetings related to budgets and site payments.
• Has internal contact with relevant departments such as Drug Safety, Clinical Operations, Legal, Medical Affairs Operations, and others as necessary.
• Participate in clinical study team meetings.
• Perform Medicare coverage analyses and may train staff or other departments.
• Coordinate CRO relationships and manage performance.
• Help foster good relationships with clinical investigators.
• Ensure compliance with Exelixis' policies and procedures.
• May hold the role of Investigator Budgets (IB) Process Manager for Investigator-Sponsored Trials (ISTs) FMV negotiations, EXEL-Sponsored Trials (ESTs) escalations and quality control (QC), Contract amendments, Data team, etc., and is responsible for the developing work instructions, internal and external training, managing workload and preparing and monitoring tracking systems.
• With the appropriate competency and skills, may supervise staff, assign work, and perform performance appraisals.

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Exhibits Exelixis Leadership Commitments :

Lives The Exelixis Core Values Daily :

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