Arka Moitra
Quality Management in cFSP at IQVIA | CAPA Champion | Expert in Quality Management and Clinical Operations in Clinical Research
- Role
- Sr Quality Specialist - Quality Management (Clinical Fsp Model) at IQVIA
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Arka Moitra
With 13 years of experience in clinical research operations and quality management, my background includes roles such as Quality Manager, Compliance Manager (sponsor dedicated), Regional Clinical Lead, Centralized Monitoring Lead, Clinical Research Associate, and Clinical Trial Coordinator. My current responsibilities focus on quality management, process development, risk management, resolution of quality issues, and CAPA development at IQVIA. I possess over 6 years of on-site monitoring expertise, overseeing feasibility assessments, site evaluations, study start-ups, initiations, monitoring, and close-out visits for Phase trials across diverse therapeutic areas, including Oncology, Rheumatology, Nephrology, Vaccines, Cardiovascular, Respiratory, Infectious, Rare, and Orphan Diseases in India, Sri Lanka, and Malaysia. Certified in Clinical Trial Auditing Principles by Pharm-Olam Audit Academy.
Experience
Sr Quality Specialist - Quality Management (Clinical Fsp Model)
Nov 2022 — Present · IN
Education
West Bengal University of Technology, Kolkata
Bachelor Of Pharmacy, Pharmacy
2004 — 2008
Jadavpur University
Post Graduate Diploma, Clinical Research and Regulatory Affairs
2011 — 2012
Skills
- Clinical Trials
- Pharmacovigilance
- Ich-Gcp
- Oncology
- Protocol
- Good Clinical Practice (Gcp)
- Clinical Development
- Regulatory Affairs
- Clinical Monitoring
- Clinical Data Management
- Clinical Research
- Clinical Pharmacology
- Diabetes
- Software Documentation
- Edc
- Ctms
- Hospitals
- Documentation
- Gcp
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