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Karthick Kumar R User

@karthickkumarruser

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Clinical Research professional with expertise in TMF management.

India

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What I'm looking for

I am seeking a role that fosters collaboration and offers opportunities for professional growth in clinical research.

I am a Clinical Research professional with over 6.5 years of experience, specializing in TMF oversight and management. My journey includes more than 4 years of dedicated work in TMF oversight at Parexel and Syneos Health, where I honed my skills in eTMF management using Veeva Vault. I have a proven track record of ensuring audit readiness and conducting thorough document quality reviews, which has been recognized through the Country Head Annual Award for excellence in sponsor study documentation.

My expertise extends to a strong understanding of ICH-GCP guidelines, CTMS, and the clinical operations lifecycle. I have successfully managed TMF setups, maintenance, and closures, ensuring compliance with SOPs and regulatory standards. My collaborative approach has allowed me to work effectively with cross-functional teams, contributing to continuous improvement initiatives and ensuring high-quality documentation throughout the clinical trial process.

Experience

Work history, roles, and key accomplishments

TMF Reviewer

Parexel International

Jul 2023 - May 2025 (1 year 10 months)

Conducted completeness and milestone reviews of TMFs for multiple global studies, ensuring compliance with SOPs and sponsor requirements using Veeva Vault. Participated in internal/external audits, enabling inspection readiness and delivering high-quality documentation.

Veeva TMF ICH GCP Clinical Documentation

TMF Specialist

Syneos Health

Mar 2021 - Jun 2023 (2 years 3 months)

Managed TMF setup, maintenance, and closure in line with SOPs and ICH-GCP guidelines. Performed quality reviews and compliance checks of documents submitted for entry into the TMF, liaising with project teams to resolve issues.

TMF ICH GCP Compliance

Medical Coder

Episource

Jun 2018 - Dec 2020 (2 years 6 months)

Transcribed patient histories into standardized codes, ensuring accurate documentation for diagnoses and treatments. Reviewed and audited medical records to maintain data integrity.

Medical Coding Medical Records Review Auditing Patient History Transcription

Education

Degrees, certifications, and relevant coursework

Anna University

M.Tech, Biotechnology

2018 - 2021

Grade: 9.05 CGPA

Completed a Master of Technology in Biotechnology, focusing on advanced biotechnological concepts and research. Achieved a strong academic record with a CGPA of 9.05.

Anna University

B.Tech, Biotechnology

2014 - 2018

Grade: 8.43 CGPA

Obtained a Bachelor of Technology in Biotechnology, building foundational knowledge in the field. Maintained a commendable academic performance with a CGPA of 8.43.