[Hiring] Clinical Trials Manager @Bristol Myers Squibb

Role Description

The 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.

Job 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.
• Up to 20% travel required.

Qualifications

• Minimum 5-7 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.
• Applies AI to improve team execution and decision-making.

Benefits

• Eligibility to participate in 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, along with 11 paid company holidays each year.
• 160 hours of paid vacation annually for non-exempt employees, along with 11 paid company holidays and 3 optional holidays.
• 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.