Regulatory compliance (cgmp, 21 cfr part 11, ich e6)
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 IRT projects as a strategic partner, ensuring on-time delivery and adherence to BMS standards and quality principles, while managing vendor relationships and ensuring regulatory compliance.
Bristol Myers Squibb offers uniquely interesting work, life-changing careers, and a supportive culture with a wide variety of competitive benefits and programs.
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 deployment
Vendor performance quality management
Regulatory compliance (cGMP, 21 CFR Part 11, ICH E6)
Clinical trial management systems knowledge
Clinical supplies understanding
Data quality and integrity standards
Nice-to-have
Excellent communication and analytical skills
Ability to think outside the box
Collaboration with global teams
Change agile environment adaptability
Process improvement leadership
Key Requirements
Bachelor’s Degree
Minimum 5 years work experience in health science or related IRT industry
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 and regulatory audit teams
Excellent English language written and verbal communication
Comfortable working with a global team
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