Mgr, Database Management Systems
Core
Designing and modifying data models, organizing metadata, and developing global clinical data standards (CDISC/SDTM) to support clinical trial data collection and management.
Role type
Senior Manager, Clinical Data Standards & Global Library Management
Builds
Global clinical data standards, operational data mappings, and Medidata Rave global library standard objects (eCRF forms, edit checks)
Domain
Clinical Research / Life Sciences / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Medidata RAVE expertise, C# programming, CDISC standards governance (SDTM/CDASH), global library development, data mapping specifications
Preferred skills
Drug development process knowledge, GCP/ICH compliance, EDC tools (Veeva, Oracle), database/dictionary structures (MedDRA, WHODrug), SDLC principles
Technologies
Medidata Rave, C#, CDISC SDTM, CDASH, ADaM, define.xml, MedDRA, WHODrug
Responsibilities
Develop and maintain global clinical data standards and operational mappings; manage work assignments for global library objects; support Standards Governance Committees; liaise with external partners and project teams; provide mentoring and training on data standards processes
Seniority
Manager, strategic focus with hands-on technical expertise
