Sr Clinical Trial Manager, Clinical Operations
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA, focused on improving survival for people with cancer by harnessing the power of targeted radioisotopes. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. The company is developing innovative radiopharmaceutical drugs against targets of solid tumors and aims to be the global leader in radiopharmaceuticals.
About the role
The Sr. Clinical Trial Manager, Clinical Operations is responsible for the oversight, planning, and delivery of assigned clinical studies within RayzeBio programs. This role ensures studies are conducted in compliance with corporate and program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines, and applicable federal (FDA) and state regulations. The position involves managing Clinical Research Organizations (CROs) and vendors to achieve study goals within timelines and budget while maintaining the highest quality.
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 cross-functional study execution teams to achieve 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.
- Identify, assess, and mitigate operational risks; escalate issues as needed.
- Manage study CRO and vendor budgets and invoicing procedures according to study contracts.
- Lead or support country and site feasibility, selection, and activation strategies.
- Actively participate in CRO and vendor meetings, review 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 or Head of Clinical Operations.
- Perform other related duties as assigned.
Up to 20% travel required.
Requirements
- Minimum 5-7 years of clinical operations experience within biotech, pharma, or CRO industry.
- BA/BS degree, preferably in a scientific or healthcare discipline.
Skills
- 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 Environment
The noise level in the work environment is usually moderate.
Pay
Remote - United States: $149,860 - $181,595 (full-time employee basis). Additional incentive cash and stock opportunities may be available based on eligibility. The starting pay rate considers required skills, job location, work schedule, job-related knowledge, and experience. Final compensation will be determined based on demonstrated experience.
Benefits
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Work-life Benefits:
- US Exempt Employees: Flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or RayzeBio employees).
- Phoenix, AZ, Puerto Rico, and RayzeBio Exempt/Non-Exempt/Hourly Employees: 160 hours annual paid vacation for new hires (with manager approval), 11 national holidays, and 3 optional holidays.
- Additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence (medical, personal, parental, caregiver, bereavement, and military), and an annual Global Shutdown between Christmas and New Year’s Day (eligibility applies).
Eligibility for benefits may vary based on job and location. All global full- and part-time employees actively employed and paid directly by BMS at the end of the calendar year are eligible for the Global Shutdown.