Clinical Operations

• Manage global clinical study teams, CROs and vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs, FDA regulations and ICH/GCP guidelines.
• Leads the cross-functional study execution team in achieving the study goals and deliverables.
• Plan and execute study timelines.
• Develop and manage risk mitigation strategies for clinical studies.
• Tracks, monitors and reports on study progress and proactively escalates issues to key internal stakeholders to ensure timely resolution of issues.
• Manage study CRO and vendor budgets and invoicing procedures according to study contract.
• Perform oversight review and quality control of CRO and vendor scope of activities, ensuring compliance to key performance metrics and overall inspection readiness.
• Active participant in CRO and vendor meetings, responsible to review key CRO and vendor study operational plans and provides input to operational strategy, including country and site feasibility and start-up.
• Summarizes CRO and vendor performance data and escalates study risks to the Head of Clinical Operations.
• Performs other related duties as assigned.

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