Abhay Kumar Gowda
@abhaykumargowda
Detail-oriented TMF specialist driving quality and process efficiency.
IndiaWhat I'm looking for
I am a detail-oriented TMF professional with hands-on experience in eTMF classification, Quality Control (QC), Retrospective QC, and document lifecycle management across global clinical studies. I leverage Power BI, Smartsheet, and AI tools to improve data accuracy, automate workflows, and maintain audit-ready TMFs in compliance with SOPs, ICH-GCP, and sponsor requirements.
I have progressed through roles from Centralized Study Associate to TMF Classifier II, led the Know Your TMF (KYTMF) learning initiative, supported audits and CAPA activities, and created visual and video-based training materials. I drive continuous process improvement, mentor junior staff, and contribute to cross-functional teams to enhance TMF quality and operational efficiency.
Experience
Work history, roles, and key accomplishments
TMF Classifier II
Fortrea
Aug 2025 - Present (4 months)
Manage and maintain eTMF for clinical studies, leading classification, QC and audit-readiness activities while driving process improvements and AI/Power BI automation to enhance document accuracy and workflow efficiency.
TMF Classifier I
Fortrea
Jul 2023 - Aug 2025 (2 years 1 month)
Performed document classification, indexing and retrospective QC across trial, country and site levels ensuring SOP and sponsor compliance and supporting audits and CAPA implementation.
Centralized Study Associate I
Labcorp
Aug 2022 - Jul 2023 (11 months)
Supported centralized study operations including eTMF document processing, quality checks and metrics reporting while collaborating with global study teams to resolve TMF operational issues.
Delivery Associate
Amazon Flex
Jan 2019 - Jan 2020 (1 year)
Executed delivery assignments with punctuality and accuracy, maintaining high customer satisfaction and time management standards during contract tenure.
Education
Degrees, certifications, and relevant coursework
JRJSS Academy of Higher Education and Research
Master of Science, Microbiology
2020 - 2022
Completed Master of Science in Microbiology with coursework and training in microbiological techniques and research methods from 2020 to 2022.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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