Clinical Trials 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
• Leads the cross-functional study execution team in achieving the study goals and deliverables
• Plan and execute study timelines
• Maintain 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
• Summarizes CRO, vendor and site performance data and escalates study risks to the Clinical Operations Program Lead / Head of Clinical Operations
• Perform 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

Work Environment

The noise level in the work environment is usually moderate. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.