Clinical Trials Manager, Clinical Operations
About The Position
The Clinical Trial Manager, Clinical Operations oversees, plans, and delivers assigned clinical studies within RayzeBio programs. The role manages study CROs and vendors in compliance with corporate and program SOPs, GCP/ICH guidelines, and applicable federal and state regulations, with the goal of meeting study objectives on time, within budget, and to high quality standards. The position leads trial planning, execution, and closeout for Phase I–III studies and coordinates cross-functional study teams, timelines, study monitoring, risk management, feasibility, site activation, budgets, and vendor performance. Up to 20% travel is required.
Requirements
- Minimum 5–7 years of clinical operations experience within the biotech, pharmaceutical, or CRO industry.
- 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.
Nice To Haves
- BA/BS degree, preferably in a scientific or healthcare discipline.
- Expertise in Microsoft Project and Smartsheets.
- Applies AI to improve team execution and decision-making.
Responsibilities
- Lead the planning, execution, and closeout of clinical trials from Phase I–III.
- Oversee and manage CROs and vendors to ensure studies are completed on time, within budget, and in compliance with RayzeBio SOPs, FDA regulations, and ICH/GCP guidelines.
- Lead the cross-functional study execution team in achieving study goals and deliverables.
- Plan and execute study timelines.
- Monitor study progress, including enrollment, site performance, data quality, and key risk indicators, and proactively escalate issues to internal stakeholders for timely resolution.
- Identify, assess, and mitigate operational risks; escalate issues as needed.
- Manage study CRO and vendor budgets and invoicing according to study contracts.
- Lead or support country and site feasibility, selection, and activation strategies.
- Participate in CRO and vendor meetings, review key operational plans, and provide input on operational strategy, including country and site feasibility and start-up.
- Summarize CRO, vendor, and site performance data and escalate study risks to the Clinical Operations Program Lead / Head of Clinical Operations.
- Perform other related duties as assigned.
Benefits
- Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
- Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
- For non-exempt employees, RayzeBio employees, and employees in Puerto Rico: 160 hours of paid vacation annually for new hires, subject to manager approval.
- 11 paid company holidays annually.
- Three optional holidays for non-exempt employees, RayzeBio employees, and employees in Puerto Rico.
- Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leave for medical, personal, parental, caregiver, bereavement, or military needs.
- Eligible employees receive an annual Global Shutdown between Christmas Day and New Year's Day.
- May be eligible for discretionary incentive cash and stock opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
