Key Skills :
At least 5 years of experience in the clinical data management domain in Pharma/CRO industry. Experience in, development of data management documents, development of validation plan, screen UAT, edit check UAT, clinical data query management etc.
- Data Management Plan: list of activities in clinical trial
- Check if designing is as per the Rules designed by programmer
- Data cleaning and ensure error free data is entered example: age criteria is 18-65 but someone entered 74 years then system has to file a query and data coordinator would check if the query is filed correctly and raise with the concerned who put 74.
- Master data management: filing process basis index as its subjected to audits and inspections. Do QC of eTMF (Trial Master File)
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