Primary Responsibility

Description

a-CRF

To prepare the Annotation CRF using Skilled Adobe Acrobat.

SDTM and ADaM Programming as per CDISC Guidelines

1. Creation of SDTM and ADaM mapping specification sheet, modify and maintain SAS programs.

2. To prepare CDISC database as per CDISC standards and regulatory deliverables. (Define xml., SDTM aCRF).

Creation/Modification of Macros for repetitive tasks

To use SAS Macro for repetitive tasks.

Metadata and Define.xml file creation

To Create Metadata and define.xml file (Using Pinnacle 21)

cSDRG and ADRG Guide Preparation

To prepare the cSDRG and ADRG report as per FDA guideline.

Validation of CDISC (SDTM and ADaM) outputs

1. Identify and edit checks as per the data validation

2. To Run Pinnacle 21 validator on clinical trial data and troubleshoot finding with stakeholder.

SOP Training

To complete internal SOP/CLP training as in timely manner

QA response with in the timelines

To provide QA response within the timelines.

📌 Sas Programmer (Gujarat)
🏢 Veeda CR
📍 Gujarat