Clinical Data Standards & Metadata Repository -
- Implement an enterprise wide, ISO1179 compliant metadata repository, managing change in terms of people, processes and technology.
- Design processes for maintaining a metadata repository (curation of standards, uploading, reviewing of standards)
- Design To Be processes for governing clinical data standards
- Design enterprise wide governance organization
- Gather requirements for integration of metadata repository with applications in clinical life cycle
- Ensure metadata driven clinical processes for CRF design, SDTM, ADaM
Business Analysis –
- Draft BPMN compliant process maps using Enterprise Architect software
- Analyse As Is pr...