Life at BMS
At RayzeBio, every day is an opportunity to ignite meaningful change. 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. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer.
Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals
Sr. Clinical Trial Management Associate, Clinical Operations
Summary
The Senior Clinical Trial Manager Associate is responsible for key clinical vendor planning and management for the assigned clinical study(ies) within the RayzeBio programs 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 Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
- ✓Manage study vendors, including but not limited to, Central Lab, RTSM/IRT, Imaging, Dosimetry Vendors to ensure vendor deliverables are on time, within budget, and in compliance with RayzeBio SOPs, FDA regulations and ICH/GCP guidelines
- ✓Active participant in vendor meetings and responsible for vendor study operational plans, development and management of risk mitigation strategies, and review of key performance indices and other vendor metrics
- ✓Assist the Study Lead with the management of the study CRO, including the review of the Clinical Study Protocol, Informed Consent Forms and other study documents and plans
- ✓Active participant in CRO and Study Execution Team meetings and provides input to operational strategy, including study and country start-up
- ✓Support site management activities, including site feasibility and selection, initiation, and issue resolution
- ✓Track and maintain study documentation, including Trial Master File (TMF) completeness and quality
- ✓Tracks, monitors and reports on study vendor progress and proactively escalates issues to key internal stakeholders to ensure timely resolution of issues
- ✓Assist/manage study vendor budgets and invoicing procedures according to study contract
- ✓Summarizes vendor performance data and escalates study risks to the Study Lead
- ✓Performs other related duties as assigned
- ✓Up to 10% travel required
Uses AI tools to enhance individual productivity and quality of work
Education and Experience
- ✓Minimum 2-3 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.
Work Environment
The 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: $119,116 - $144,341