Senior Director, Data Management Systems

Responsibilities

• Lead, mentor, and develop a team of clinical trial solutions personnel
• Own the enterprise strategy, roadmap, and governance for eCOA/ePRO, eDiary, Medidata Rave EDC, and Elluminate
• Oversee computer system validation (CSV/CSA) ensuring compliance with 21 CFR Part 11 and GxP
• Lead architecture and oversight of system integrations (EDC-to-eCOA, EDC-to-Elluminate)
• Manage system-related budgets, vendor contracts, and licensing decisions
• Serve as the primary systems liaison to Clinical Data Management, Biostatistics, and IT

Requirements

• Bachelor's degree in life sciences, health information, computer science, or related field
• 15+ years of progressive experience in clinical data management and/or clinical data systems
• 5+ years of people management experience
• Demonstrated experience administering eCOA/ePRO, eDiary, Medidata Rave EDC, and Elluminate
• Strong knowledge of system validation (CSV/CSA), 21 CFR Part 11, and ICH-GCP

Preferred Qualifications

• Experience across multiple therapeutic areas and trial phases (I–IV)
• Familiarity with IRT/RTSM, CTMS, safety databases, and eTMF
• Certification in clinical data management (CCDM), ITIL, or PMP
• Experience with system integration architecture and APIs

About the Company

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative anti-FcRn technology.