To prepare the Annotation CRF using Qualified Adobe Acrobat.
Creation of SDTM and ADaM mapping specification sheet, modify and maintain SAS programs.
To prepare CDISC database as per CDISC standards and regulatory deliverables. (Define xml., SDTM aCRF).
To use SAS Macro for repetitive tasks.
To Create Metadata and define.xml file (Using Pinnacle 21)
To prepare the cSDRG and ADRG report as per FDA guideline.
Identify and edit checks as per the data validation
To Run Pinnacle 21 validator on clinical trial data and troubleshoot finding with stakeholder.
To complete internal SOP/CLP training as in timely manner