Jitendra Solanki

Background

About Jitendra Solanki

Software Testing & Computer System Validation (CSV) Professional- Profound knowledge in Clinical Trials, Life Sciences, EDC, eCOA, ePRO, eConsent, IRT and IWRS- Good knowledge of Regulatory Guidelines, ICH-GCP, US FDA, EU GMP and international regulations such as 21 CFR Part 11, GAMP, Annex11 and GxP systems- Validation of EDC, ePRO/eCOA system, eConsent, IRT, eCRF to ensure adherence with GxP regulations- Good understanding of Requirement Analysis, Functional Specification, design and review Test Cases, RTM, Test Plan & Test Design for Functional Testing, UAT, Regression and End-to-end Testing- Preparation and review of Validation Protocols IQ/OQ/PQ documentation, Validation Plan, Validation Summary report and Risk Assessment- Hands on experience in Clinical Report testing includes Adverse Event Report, SAE, Subject Visit Report, Audit Trial Report, Site Status Report, Listing of Subjects, Subject Portal, annotated CRF- Coordinate with cross functional teams, SW development teams, BA Team to meet project requirements and review validation documentation to support projects- Provide Training, KT and mentor juniors about EDC system, CRF and data validation, QC checks, SOP’s and project specific requirements- Verifying change requests, change control and defects; documenting, tracking- Work exp. on Jira, TestRail, TFS, Postman and Beyond Compare- Work experience in Data Exports, SAS dataset validation, CDISC SDTM, ADaM and Define.xml standards- Implementation and mapping of CDASH data to SDTM and Pinnacle 21 Enterprise Validation.