Manager, Clinical Supply Systems
Core
Manage Investigational Regional Trial (IRT) systems for Moderna's clinical studies, ensuring alignment with internal stakeholders and timelines while overseeing vendor operations.
Role type
Manager, Clinical Supply Systems (IRT)
Builds
IRT system designs, implementations, and maintenance for clinical trials
Domain
Biopharma / Clinical Research Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IRT system management, project management, user acceptance testing (UAT), vendor relationship management, regulatory compliance (ICH, GAMP, FDA, IRB/IEC), cold chain distribution knowledge, cross-functional collaboration
Preferred skills
Product Ownership experience, system integration innovation, mentoring
Technologies
MS Office (Outlook, Word, Excel, PowerPoint, SharePoint), eTMF
Responsibilities
Manage IRT systems for assigned programs with autonomy; lead IRT implementation, requirements gathering, design, and maintenance; facilitate UAT and documentation signatures; support Clinical Operations and Monitoring teams; serve as IRT Subject Matter Expert
Seniority
Manager, hands-on IC with some mentorship
