Experienced Data Analyst with a post graduation in Medical Biochemistry and Advanced Diploma in Clinical Research Data Management and Regulatory Affairs. Certification in ICH-GCP and Bioethics.-Drug development, clinical research (phases I-IV).-Clinical data management and electronic data capture softwares Oracle, Veeva vault, Medidata Rave, OpenClinica, Siro, AB Cube Safety Easy, Clinion, NCDIR.-Data entry using REDCap.-Case report form (eCRF) filing.-Pharmacovigilance and Medical writing knowledge.-Coding using MeDRA/WHODrug.-Discrepancy and safety data management by query forms ArisGlobal and Argus softwares.-Market research analysis.-Patient registration, appointment scheduling, billing, inventory, laboratory, of Hospital, Laboratory and Information Systems (eHIS/LIS) healthcare software NIC, MocDoc.-Scientific data curation from publications and research articles, journals.-ICH-GCP and Bioethics trained from National Cancer Grid-Tata Memorial.-Data extraction, data validation and analysis using Boolean operators.-Systematic literature review, Meta-analysis.-Knowledge in HIPAA/HL7, NDCT rules.-eTMF knowledge.-Regulatory dossier preparation for Ethics Committee submission.-Preparation and review of Standard Operating Procedures.-Coordinate and supply of clinical study equipment.-Knowledge in regulatory documents CTRI, MoU, PSP, investigator brochure, DHR approval letter, clinical trial liability insurance policy schedule, investigator undertaking.-Protocol deviation and amendment.-SAE documentation and reporting in SUGAM portal.-Drug accountability.-Well-versed in study start up/site initiation, interim analysis, site monitoring, close out visits, auditing, inspection. inspection, source data verification and archival of documents.-Preparation of utilization certificate and statement of expenditure, tax invoices, purchase order for study budget and finance needs with sponsor.