Dr Mukesh Kumar Email & Phone Number

Having overall experience of 5+ years in Clinical Data Management in Clinical Research Organisation.•Having an in-depth knowledge and experience in Classic Medidata RAVE and Medidata Rave X within the Clinical and Data management domain.•Management of the end to end activities in Phase I, II, III, therapeutic studies for COVID-19, Respiratory, Oncology, Pancreatic tumors, Gastric.•Having an experience of Discrepancy Review/Query Resolution and SAE Reconciliation, Edit check Specification, UAT, ELVIS, Veeva Vault.•Involved in the Study Start up, Conduct phase and Close out activities.•Involved in Biweekly, monthly Listing review for missing data and Query management issues.•Study Start up: Input the eCRF design as per protocol, Set up the Guidelines document end to end pertaining to the study, Review of Annotated study build, created new checks and performed the Edit check specification Review, also the same carried out in UAT Rave.•The SAS Listing specification template designing and review per study requirement was also done.•Actively involved in performing archival activities for multiple studies in ELVIS.•The budgeting for the study was designed and projections were made accordingly. •Primarily handled the end to end activities and Start-up activities and also involved in Reviewing the Subject data for 8-10 studies. •Support User Acceptance Testing (UAT) for validation (edit) programs as requested. Test data entry screens per data entry guidelines and Case Report Forms (CRFs) for selected projects and collaboration with the data team lead.•Study Conduct Phase: Involved in Manual data review (SAS Listings in Excel): Identifying the true Abnormal values, Discrepant data, Missing data, Duplicate data, Programming issue, Conversion error, Protocol deviation, SAE reconciliation and Query management (Issue manual queries or closing the queries).•Study Close out: Ensure all DM activities are complete in eCRF, Final Data listing review, Check for all data discrepancies are resolved, Resolve or close all open queries and Source data Verification(SDV) is completed followed by Database lock and also involved in several IA lock and DBLs.•Independently perform additional data cleaning tasks which includes logic checks using listings and reports as needed, SAE reconciliation, and identification of issues and EDC dataset QC, perform interpretations of compare output and provide feedback to Project Data Manager for resolution and database edits.

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  Nirmala College Of Pharmacy

  Pharm D