Manages IRT for multiple studies, including system development, vendor oversight, change management, and data provisioning, while supporting UAT Services
Job Summary
Manages IRT for multiple studies, including system development, vendor oversight, change management, and data provisioning, while supporting UAT Services.
Leads successful execution and on-time delivery of IRT, supporting integrations with other clinical systems and ensuring adherence to BMS standards and quality principles.
Ensures systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2), and BMS SOPs and processes.
Matching Summary
Manages IRT for multiple studies, including system development, vendor oversight, change management, and data provisioning, while supporting UAT Services.
Skills & Requirements
Must-have
IRT system development and oversight
Clinical trial supply chain integration
Vendor performance management
Regulatory compliance (cGMP, 21 CFR Part 11, ICH E6)
User Acceptance Testing (UAT) of IRT systems
Nice-to-have
Strategic partnership and accountability
Process improvement initiatives
Global team collaboration
Change agile environment
Key Requirements
Minimum of 5 years work experience
Bachelor’s Degree
Clinical Research experience
Working knowledge of IRT
Working knowledge of Clinical Trial Management Systems