Dr.Harish Rawat's Linkedin Analytics

More then 18 Years Broad Experience in Clinical Research Industry.Specialley in Clinical Data Mangement(Clintrial and Inform Database) ••Discrepancy Management: Performing cleaning of Clinical research data in CT scan, ePIC (paper trials with Clintrial as CDMS) and InForm (EDC) and resolving discrepancies. •Clinical Diagnostic Services: Performing Central lab data review and reconciliation as per study specific Lab mapping guidelines and DQDP. •SAE Review and Reconciliation: Reviewing of Reports for Potential Unreported SAE in InForm and ePIC and reconciliation of Serious Adverse Events, to ensure the consistency between the Safety Database and the CDMS. •WHO Drug Coding: Interactive WHO Drug Coding of Medications (Concomitant and Previous Therapy) in Clintrial Communicating any changes in Safety Database to Global Product Safety (GPS). •InForm Reporting: Generation of Report for InForm data using Adhoc tools, running various validation checks on those to ensure quality and integrity of clinical data complied with ICH-GCP and client requirement. Tool. Reviewing of MedDRA Candidate queries for uncoded Adverse Event Terms. •Purging: Purging all records from Validation and Coding Log in Clintrial whenever necessary. •Data Review: Performing clinical data review activities as per Data Review Plan. •Training: Impart CDMS and Data Validation training to New Joiners. •Reviewing of Validation and Coding Log to ensure that validation is completed without error and also reporting any error found to CDMC. •CDR (Comprehensive data review): Performing CDR checks included in the study specific DQDP (Data Quality Delivery Plan). •Coordinating with CDMCs via Mails and teleconferences regarding issues with Clinical Data. Specialties: Clinical Data Management. Tools used:Clintrial, Inform(EDC), i review ICCand Infuse,WHO Coding, Infuse coding, MEDRIO(EDC) and Team Management, SLA Tracking and Monitoring,Process Improvement, People Management