Varun Pandya

About Varun Pandya

I have 12+ years of experience in clinical data management field with various roles. START UP:• Database build Activities:(RAVE, IBM CD, Medrio,RMP)• Trained on Veeva Vault- eCRF design- Edit check programming- ePRO setup- Safety alerts programming- eConsent programming- Lab module setup- Edit check specification creation- Database defined reports• Validation/UAT Activities- eCRF Validation-Database validation (InForm, RAVE, IBM CD, INES, Infosario Outcome, Medrio, RMP)- SAS listings validation- Custom reports validation- Data transfer validation- Lab module validation- System settings validation• CONDUCT:previously worked with data management team as POC for multiple studies in different therapeutic area such as Respiratory, Metabolic disease, Cardiovascular disease, Autoimmune disease etc. Worked on query management, Lab reconciliation, IVRS reconciliation, SAS & Manual listings, data QC during my work as a data manager. I have also worked with data entry team for PRO & Patient diary data entry and QC. preparation of SOP, Work instructions, best practices documents, operational manual etc. • CLOSEOUT:Worked on data archiving activities on client specific tools. I have worked on CDMS to manage study documents. I have also worked on archiving of physical documents related to study activities. • MISCELLANEOUS:I am LEAN SIX Sigma certified during my tenure with TCS. after that I was actively involved in FMEA preparation for data entry and data management team. I have worked as process trainer for data entry team and validation team.

Experience

1. Principal Technical Designer

   IQVIA

   May 2025 — Present · Mumbai, IN

Education

• CLINI INDIA

  Advanced Postgraduate Program In Clinical research & management, CLINICAL RESEARCH

  2013

• Gujarat Technological University (GTU)

  B.pharm, Pharmaceutical

  2008 — 2012

Skills

• Regulatory Submissions
• Oncology
• Informatics
• Protocol
• Formulation
• Clinical Data Management
• Anda
• Medical Devices
• Clinical Research
• Clinical Pharmacology
• Uv/Vis
• Medical Affairs
• Gcp
• Regulatory Requirements
• Ectd
• Drug Delivery
• Pharmacists
• Glp
• Diabetes
• Pharmaceutical Research
• Validation
• Infectious Diseases
• Hplc
• Ich Guidelines
• Biotechnology
• Pharmacovigilance
• Gmp
• Pharmaceutical Sales
• Pharmaceutical Industry
• Sop
• Parentral Production [Powder Injectable]
• Clinical Development
• Fda
• Drug Safety
• Therapeutic Areas
• Pharmacology
• Ctms
• Clinical Operations
• 21 Cfr Part 11
• Pharmaceutics