Sr. Clinical Trial Manager, Clinical OperationsThe Sr. Clinical Trial Manager, Clinical Operations is responsible for the oversight, planning and delivery of assigned clinical study(ies) within the RayzeBio programs, including oversight and management of the study Clinical Research Organization (CRO) and Vendors according to and in compliance with corporate and program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state regulations, in order to achieve established study goals within timelines and budget and of the highest quality.
Job ResponsibilitiesEssential duties and responsibilities include the following. Other duties may be assigned.
- 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
Education and Experience- Minimum 5-7 years clinical operations experience within biotech, pharma or CRO industry
- BA/BS degree, scientific or healthcare discipline preferred
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.
- Applies AI to improve team execution and decision-making
Work EnvironmentThe noise level in the work environment is usually moderate.
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:Remote - United States - US: $149,860 - $181,595
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides 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 also have access to additional time-off benefits, including 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 also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
RayzeBio and Bristol Myers SquibbRayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.
