CDM professional with 9+years of exp.
Create and review the generation of Clinical Data Management documents
(DMP, Annotated CRF, Database Specifications, Data Validation Plan, Data Entry and Review Guidelines, CRF
Completion Guidelines, SAE Reconciliation Procedure and Data Transfer Agreements for assigned studies).
Generate data queries and perform data discrepancies.
• External Data Reconciliation- SAE, Lab, Biomarker, PK, IVRS.
• UAT validation and test data creation