Clinical Trial Manager, Clinical Operations

Job Responsibilities

• Lead the planning, execution, and closeout of clinical trials from Phase I–III
• Oversees and manages 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
• Led the cross-functional study execution team in achieving the study goals and deliverables
• Plan and execute study timelines
• Monitor study progress, including enrollment, site performance, data quality, and key risk indicators and proactively escalates issues to key internal stakeholders to ensure timely resolution of issues
• Identify, assess, and mitigate operational risks; escalate issues as needed
• Manage study CRO and vendor budgets and invoicing procedures according to study contract
• Lead/support country and site feasibility, selection, and activation strategies
• 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, vendor and site performance data and escalates study risks to the Clinical Operations Program Lead / Head of Clinical Operations
• Performs other related duties as assigned

Skills and Qualifications

• Independent professional who proactively communicates frequently and effectively
• Detail and action-oriented, organized and committed to quality and consistency
• Ability to work successfully in cross-functional teams
• Ability to work in a dynamic environment with a high degree of flexibility
• Expertise in Microsoft Project and Smartsheets desired