- Briefly describe the major duties and responsibilities for which the job is held accountable (what the job does, why is it done/impact)
- Collaborates with the project team to help gather technical requirements.
- Creates and maintains the following documents for the Rare Disease Registry web-based EDC and reporting technology platform: eCRF database specifications, data validation (edit checks) specifications, report specifications, and other functional specifications.
- Creates UAT Plans, writes systematic and detailed UAT test scripts, and executes testing.
- Provides peer review/QC of technical specifications/documentation to ensure consistency and accuracy.
- Collaborates with the technical vendor on database changes and ensures requirements are implemented correctly.
- Collaborates with the technical vendor and data management team to troubleshoot database bugs/issues from root cause to resolution.
- Develops training materials and provides training on technical applications to data management peers and Site Operations personnel.
- Collaborates with the Data Management team to define and develop operational reports to assist with data exploration and metrics.
- Collaborates with the Data Management team in the development of global, inter-departmental harmonized SOPs, and registry specific guidelines.
CRF design, data review, EDC systems, UAT , SDLC