Sr Clinical Trial Manager, Clinical Operations

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 Manager, Clinical Operations Summary The 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.

Essential 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