Hirok Dyuti Roy

About Hirok Dyuti Roy

Experienced Master Degree with a demonstrated history of working in the pharmaceuticals industry. Skilled in U.S. Food and Drug Administration (FDA), Electronic Data Capture (EDC), Clinical Research, Institutional Review Board (IRB), CRO Management, Central laboratry services. Strong professional with a MSCR focused in CLINICAL RESEARCH. from Medical University of South Carolina. Presently working with Eurofins Analytical services as Associates Investigator Services.Previously worked with IQVIA and ICON plc as a Sr.CPA and TMF Specialist respectively. Experienced in Laboratory Data, Data cleaning, query raising and solving and analysing lab data, performing QC on site related orders and communi cating the lab value Alerts, also resolving the project team and client query related to the laboratory data, multiple E-TMF systems for multiple clients, Folder structure such as Documentum, Share point,erooms. Exposed to different types of QC analysis for the evolution of TMF matrices completeness, Timeliness and Quality. Performed Document content QC, study lock preparation which include SSDL QC, remediation activities. Good knowledge about the excel. My expertise are Site management, maintaining and management of Electronic/Paper TMF, ISF/SMF, eCTD,DMF, MS Office, Creating automated tools, dashboard, report analysis, matrix,report creation, team management.

Experience

1. Associate Manager

   Fortrea

   Sep 2024 — Present · IN

Education

• Osmania University

  Bachelor of Science (B.Sc.), Microbiology, General

  2006 — 2010

• Medical University of South Carolina

  MSCR, CLINICAL RESEARCH...

  2010 — 2012

Skills

• Clinical Research
• Pharmacovigilance
• Medical Writing
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Edc
• Clinical Data Management
• Ctms
• Clinical Development
• Electronic Data Capture (Edc)
• Protocol
• English
• Sop
• Fda
• Irb
• CRO
• Gcp
• Clinical Trials
• Ich-Gcp
• Good Clinical Practice (Gcp)
• Clinical Operations