Abhinandana Patchala
Sr Clinical Data Associate @Thermo Fisher Scientific
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WORK HISTORY
Sr Clinical Data Associate @Thermo Fisher Scientific
EDUCATION
Acharya Nagarjuna University
Ph.D, Pharmaceutical Sciences
ABOUT ABHINANDANA PATCHALA
Having sound knowledge on ICHGCP, SDTM guidelines, Clinical trials and Clinical Data Management.1. Start-up Activities * Preparation of unique page identification form* Preparation of Annotated case report form (aCRF)* Preparation of Functional Design Specification form (FDS)* Designing of database screens* Performing UAT (Both Screens & Edit checks)* Preparation of CRF/eCRF completion guidelines (CCG\'s /eCCG\'s)*Knowledge on preparation of Data Management Plan (DMP) & Edit check Specifications (ESD)2. Conduct activities* Performance of Discrepancy management ( Raising and closing of queries)*Lab data review*Preparation and maintenance of the query trackers, Master trackers and data entry status trackers* Preparation and maintenance of Master Data Management File (MDMF)* Knowledge on performing Lab data reconciliations & SAE reconciliations* Knowledge on preparation of Quality Control reports (QC)3. Closeout activities* Ensure entire data of CRF\'s fed into the database correctly* Ensure data completeness, accuracy and timelines.*Training of Sites on Database & CCG\'S
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