@mayurraga
I manage global clinical trial sites, monitoring, TMF quality, and regulatory-compliant study delivery.
IndiaAt Parexel, I manage 20+ clinical trial sites across four active global studies, supporting protocol compliance, data quality, recruitment, and study execution from start-up through close-out.
I've progressed from Clinical Operations Intern to Clinical Research Associate I, filing 900+ TMF documents, resolving 600+ quality issues, and supporting Phase I-IV trials with ICH-GCP and NDCT Rules compliance.
Work history, roles, and key accomplishments
Managing 20+ clinical trial sites across 4 active global studies, ensuring protocol compliance, data quality, and study execution. Conducted site visits, performed SDV/SDR, and coordinated with sites to resolve issues and achieve enrollment targets.
Filed 900+ TMF documents and resolved 600+ TMF quality issues within 3 months for a global study close-out. Supported sites with payment processing, vendor access, and safety data queries, and implemented IRB-IEC approved amendments.
Managed TMF with 300+ document uploads per month using ALCOA+ principles, achieving audit-ready documentation with zero major findings. Supported 10+ clinical trials across multiple therapeutic areas and prepared 200+ pre-monitoring visit checklists.
Supported CTMS maintenance, site trackers, document management, and study coordination activities.
Degrees, certifications, and relevant coursework
Doctor of Pharmacy, Pharmacy
2016 - 2023
Grade: 73%
Doctor of Pharmacy (Pharm.D.) degree from Rajiv Gandhi University of Health Sciences, completed in January 2023 with an aggregate percentage of 73%.
CRA Training, Clinical Research
Completed CRA Training by Parexel International.
ICH-GCP Certification, Clinical Research
Completed ICH-GCP Certification by NIDA.
Software and tools used professionally
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