A spectrum of working experience in end-to-end clinical data management and in various phases of study set up(start-up), conduct, and closeout
- Review the clinical data and identify the discrepancies using an electronic database or through a manual review process.
- Experience in Data review and query Management of Paper study.
- Generate the Data Clarification Form (DCF) / query on discrepancy data and get the resolution from clinical investigative staff.
- Perform Data quality checks and document the process.
- Handle external data e.g., Lab(Local and Central), imaging, Pk reconciliation, and perform the data reconciliation process and resolve the data issues pertaining to the external data.
- Perform Serious Adverse Event (SAE) reconciliation and resolve the query pertaining to the SAEs.
- Perform medical coding using MedDRA, and WHO Drug as applicable, and maintain the dictionary files and versions