
manjula c.h
senior .clinical validation specialist
About
UAT activities 1. Writing edit checks 2. Reviewing Data validation Plan vrs annotated CRF 3. Creating test data (clean & dirty) 4. Testing the edit checks by using test data and finding the programming errors. 5. Updating pass/fail table 6. Reviewing project process documents. SAS output validation 1. Creating test data 2. Entering the test data in to test data base 3. Validating the output vs. test data.
india
bengaluru
research
gcp, ich gcp, clinical data management, clinical monitoring, ctms, clinical trials, protocol, edc, crf design, pharmacovigilance, clinical research, cro, oracle clinical, biotechnology, pharmaceutical industry, data management, regulatory requirements, clinical development, scripting and testing programming, rave programming, sas listings programming, reviewing of sas out put listings
Experience

senior .clinical validation specialist
covance

senior .clinical validation analyst
icon clinical research india private limited

project coordinator
i5 clinical research pvt. ltd

associate clinical data coordinator
iqvia
* Reading and understanding protocol. * Perform UAT according to Validation Plan of all applicable Data Management systems * Maintain Data Management related operational data flows. * Review reports and take actions as defined in the DMP or eCRF review manual * Perform ongoing and final consistency checks, review protocol deviation handling document and data listings to ensure that all data have been handled appropriately according to the DMP and eCRF Review Manual * Issue queries for data points that exhibit unacceptable discrepancies, including sending data correction request forms to the Client, document the status of events in a reconciliation spreadsheet, Update Project database with query resolutions, closing out queries. * Ensure that all Data Management activities are conducted in compliance with relevant regulatory requirements * Implement and promote the use of consistent, efficient quality processes to meet timelines and deliverables for the site based project teams according to specifications * Preparing edit check specification document.
clinical validation analyst ii
icon plc
* Writing edit checks * Reviewing Data validation Plan vrs annotated CRF * Creating test data (clean & dirty) * Testing the edit checks by using test data and finding the programming errors. * Updating pass/fail table * Reviewing project process documents.
Education
biotechnology
manjula c.h's Contact Information
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