Senior Director, Data Management Systems
Immunovant, Inc.
WorldwideFully remoteFull TimeHealthcare & Telemedicine
No salary statedPosted 26 days ago3w ago
Why we think you can apply
- Hiring model
- Open worldwide · the employer states no country restriction
- Work from
- Anywhere, the UAE included
Posted 26 days ago
About the role
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.
What we look for
- Bachelor's degree in life sciences or computer science
- 15+ years experience in clinical data management or systems
- 5+ years people management experience
- Experience with eCOA/ePRO, eDiary, Medidata Rave, and Elluminate
- Knowledge of CSV/CSA, 21 CFR Part 11, and ICH-GCP
Medidata RaveElluminateeCOAePROCSVGxP
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Immunovant, Inc.
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