Clinical Data Reviewer

TCS is hiring for Clinical Data Reviewer Role!!!

Location: Mumbai/Pune/Bangalore/Indore/Ahmedabad

Job Description: 

1.To be aware and to undertake any relevant and applicable trainings around SOPs, GUI & data standards. 

2.Understanding of study protocol, study tasks/activities and study milestones. 

3.Review Data Validation Specifications (DVS), eCRF screens and Test scripts for edit/SAS checks, create test scripts for UAT and other activities as specified in RACI. 

4.To perform Data review and discrepancy management as per RACI or as agreed with SDM/DMSPoC/ODM(Over-sight Data Manager). 

 5.To process, perform data load and delivery of external (vendor) data using designated tools. 

 6.To perform external (vendor) data reconciliation at agreed frequency in order to maintain consistency with the clinical database (e.g. InForm). 

 7.To escalate unresolved data discrepancies/ data trends to SDM/DMSPoC. 

 8.To coordinate with the programming team as appropriate regarding any database or for programming changes needed throughout the study. 

 9.To address & action data issues highlighted by study team as and when required. 

 10.To create and distribute data management metrics/Newsletter, listings and reports at an agreed frequency. 

 11. To conduct regular scheduled study meetings with study Study team. 

 12.To connect with vendor & monitor for addressing issues as agreed in RACI. 

 13.Perform close-out activities along with the SDM/DMSPoC, per the RACI and any applicable checklists, to produce datasets in advance of DBF (interims or final) that meets the requirements as detailed in the DMP. 

 14.Perform Post Database Release (DBR) activities & Pre-Database Freeze (DBF) activities as required based on discussion/agreement with SDM/DMSPoC to ensure quality data delivery. 

 15.To maintain in-stream archival of relevant study documents in eTMF