[Hiring] Clinical Trial Manager Associate @Bristol Myers Squibb

Role Description

The 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.

• 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.

Qualifications

• Minimum 2-3 years clinical operations experience within biotech, pharma or CRO industry.
• BA/BS degree, scientific or healthcare discipline preferred.

Requirements

• 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.

Benefits

• Comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• Flexible Time Off (FTO) for U.S.-based exempt employees, providing paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays for non-exempt employees.
• 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 various needs.
• Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees.