Rajesh Patra
Pharmaceutical / Bio-tech
About Rajesh Patra:
Detail-oriented TMF Specialist with 8+ years of experience ensuring eTMF integrity, completeness, and inspection readiness. Skilled in managing clinical documentation across phases and therapeutic areas in compliance with GCP, regulatory standards, and SOPs.
Experience
Experienced TMF Specialist with 8+ years in clinical trial documentation management. Proven expertise in maintaining eTMF quality, compliance, and inspection readiness across multiple studies and therapeutic areas. Strong understanding of GCP, regulatory guidelines, and SOPs, with a focus on accuracy, efficiency, and continuous process improvement.
Education
Master's in Pharmacy.
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