Dudekula Ashok

Senior Lead Tmf Pm at Eli Lilly And Company

Based in Bengaluru, India

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Seniority

Other

Department

Other

Location

Bengaluru

Industry

Pharmaceutical Manufacturing

Company size

58K

Contact information

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Email

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d•••••••@lilly.com

Phone

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+91 ••• •••• ••••

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Background

About Dudekula Ashok

I am a Senior TMF Project Manager with over 13 years of experience in global clinical research, specializing in Trial Master File (TMF) management, inspection readiness, and regulatory compliance. Currently, I lead end-to-end TMF operations at Eli Lilly Services India, managing activities from study start-up to close-out within Veeva Vault and ensuring alignment with ICH-GCP and ALCOA principles. I have extensive experience in audit preparedness, cross-functional collaboration, and process optimization, having contributed as a Product Owner for system enhancements and workflow improvements. With a strong foundation as a Clinical Pharmacologist and Research Coordinator, I bring practical insights into clinical trial conduct, investigational product management, and patient safety. I am passionate about mentoring teams, driving quality excellence, and implementing sustainable operational improvements. My expertise spans TMF completeness assessments, eTMF and CTMS systems, and quality reporting, enabling me to deliver high-quality, inspection-ready TMFs across complex global studies.dudekulaashok@gmail.com |+91 9845574018

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