Sr. Clinical Trial Manager

Bristol Myers Squibb

3d • $149,860 - $181,595 • Remote

About The Position

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/ Summary The Sr. Clinical Trial Manager/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.

Requirements

• Minimum 5-7 years clinical operations experience within biotech, pharma or CRO industry
• BA/BS degree, scientific or healthcare discipline preferred
• 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.

Responsibilities

• 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

Benefits

• Medical, pharmacy, dental, and vision care.
• Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• 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.
• flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
• 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior