Manages IRT for multiple studies, including system development, vendor oversight, change management, and data provisioning, while supporting UAT Services and identifying process improvements
Job Summary
Manages IRT for multiple studies, including system development, vendor oversight, change management, and data provisioning, while supporting UAT Services and identifying process improvements.
Leads IRT projects as a strategic partner, ensuring on-time delivery and adherence to BMS standards and quality principles, while managing vendor relationships and overseeing user acceptance testing.
Ensures systems and documentation comply with regulatory requirements (cGMP, 21 CFR Part 11, ICH E6 (R2)) and BMS SOPs, managing system access, data transfers, and resolving randomization/IRT issues throughout the lifecycle.
Matching Summary
Manages IRT for multiple studies, including system development, vendor oversight, change management, and data provisioning, while supporting UAT Services and identifying process improvements.
Skills & Requirements
Must-have
IRT system development
vendor oversight
change management
data provisioning
clinical trial management systems
clinical supplies knowledge
Nice-to-have
strategic partner
decision making responsibilities
collaborative relationship
change agile environment
Key Requirements
Bachelor’s Degree
Minimum of 5 years work experience
Health science or related IRT industry experience
Demonstrated analytical skills
Working knowledge of Microsoft Office including SharePoint
Clinical Research experience
Working knowledge of IRT
Working knowledge of Clinical Trial Management Systems
Working knowledge of clinical supplies
Exposure to GMP / GCP environment
MS Project, MS Visio, or other requirements visualization tools