* Demonstrates full competence when conducting the following tasks:
- Development of database build specifications
- Development of data validation specifications
- Test data creation & UAT
- Performing/ leading functional QC activities and testing
- Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.
- Data validation and cleaning
- Conduct medical coding if assigned
- Conduct SAE & third party data reconciliations
- Perform early and final database QC activities
- Database lock activities
- Maintaining Clinical Study Documents and archiving as appropriate