Shiv V.

A passionate clinical and basic research scientist with 18 years of experience in the diversified fields of basic, translational, and clinical research. Expert in planning, developing, executing, and regulating biopharmaceutical (Biologics) safety studies and biomedical devices. Proficient in class I, II, and IIa device validation, Phase I & II clinical trial development, initiation, oversight, and operational implementation. Recognized for innovative research, leadership, and fostering creative work environments across domains. Reputed for attention to detail, driving process optimization, and delivering on-time results at cost. My skill set includes Regulatory Compliance: GCP, GLP, GMP, IND preparation & submission, 510K submission Clinical Trial Management: Study protocol, SOP, MOO, SMF, CRF, and EDC systems Project management: SWOT analysis, Process optimization, Data management, analysis, and reporting, Time, cost, and HR management, PM software(s) expertise. Research: Assay Development, Viral-vector Gene therapy, Grant writing, Manuscript preparation, and publication ORCID: 0000-0002-3825-3121 American Heart Association Pre-Doctoral and Post-Doctoral Fellowship. AHA Genomic and Precision Medicine Travel Award 2018 Jefferson Award for Public Service 2010 (American Red Cross CPR/FA Instructor and member of Disaster Action Team). Mission: Translating research into clinical results, responsibly Please feel free to reach out to me.