Note: The job is a remote job and is open to candidates in USA. RayzeBio, a Bristol Myers Squibb company, is a biotechnology company developing targeted radiopharmaceutical therapies for cancer. The Senior Clinical Trial Manager oversees the planning, execution, and closeout of Phase I–III clinical trials, including CRO and vendor management, study timelines, budgets, risks, and compliance with applicable regulations and guidelines.
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
- 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
- Up to 20% travel required
Skills
- * Minimum 5-7 years clinical operations experience within biotech, pharma or CRO industry
- * BA/BS degree, scientific or healthcare discipline preferred
- * 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
- * Up to 20% travel required
- * Expertise in Microsoft Project and Smartsheets desired
- * Applies AI to improve team execution and decision‑making
Benefits
- Additional discretionary incentive cash and stock opportunities may be available.
- Eligible employees may participate in comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life and disability insurance offerings.
- U.S.-based exempt employees are eligible for Flexible Time Off (FTO), providing paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
- Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
- Depending on eligibility, employees may have access to paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
- Eligible employees enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
Company Overview
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