● Case Report Form design
● eCRF design specification
● Database design and set up
○ Interface testing
○ Logic (edit) check development,
programming & testing
● MedDRA & WHODrug coding
● External data management
● SAE reconciliation
● Support protocol deviation detection
and reconciliation
● Database quality control
● Data Management status, tracking
and progress reporting
● Develop and manage core Data
Management documents, including:
○ Data Management Plan
○ Data Reconciliation plans
○ Data Transfer agreements
○ Medical Coding plan
● Experience across multiple EDC platforms