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.

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have 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 medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings athttps://careers.bms.com/benefits