Senior Clinical Trial Manager Associate Clinical Operations

Bristol Myers Squibb

4d•$119,116 - $144,341•Remote

About The Position

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.

Requirements

Minimum 2-3 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.

Nice To Haves

Expertise in Microsoft Project and Smartsheets desired.

Responsibilities

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
Uses AI tools to enhance individual productivity and quality of work

Benefits

wellbeing support
retirement and financial protection benefits
insurance offerings (medical, dental, vision, life and disability)
Flexible Time Off (FTO)
11 paid company holidays each year
160 hours of paid vacation annually for new hires
3 optional holidays
paid sick leave
up to two paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
annual Global Shutdown between Christmas Day and New Year's Day