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Athira Suresh

Clinical Data Manager

Certified Clinical Research Professional with 3+ years of experience in EDC validation, UAT execution, and clinical data cleaning. Skilled in regulatory compliance, database validation, and cross-functional study coordination across global trials.
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3

Years of experience

Athira

About Me

I am a Clinical Data Management professional with over three years of experience in database validation, UAT execution, data cleaning, and regulatory compliance within clinical trials. My expertise includes study start-up activities, DVS validation, edit check testing, and cross-functional coordination across Data Management, Programming, QA, and Clinical Operations teams. I have supported 60+ studies across oncology, hematology, gene therapy, metabolic medicine, and general medicine, ensuring high-quality, inspection-ready data aligned with ICH-GCP and FDA 21 CFR Part 11 standards.
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My expert
areas

Expert in EDC validation, clinical database testing, regulatory compliance, and data cleaning with proven success in managing multi-study validation cycles and ensuring high-quality clinical trial data integrity.

Skills

EDC Validation & User Acceptance Testing (UAT)

Data Cleaning & Query Management

Medidata Rave, Inform, REDCap & Veeva Vault

DVS / LVS Review & CRF Validation

Regulatory Compliance (ICH-GCP, FDA 21 CFR Part 11)

Cross-functional Study Coordination

  • 60

    Studies Validated (+)

  • 100

    Edit Checks Tested (Per Study)

  • 30

    Studies Supported (Data Cleaning & Updates)

  • 100

    Patients Screened & Managed (+)

Education

Advanced Diploma in Food Science and Technology
Centennial College
Scarborough, ON
January 2022 – April 2023
Bachelor of Technology in Biotechnology Engineering
University of Calicut
India
August 2014 – May 2018

Experience

ICON PLC

Clinical Validation Analyst I | 3 Years | India

  • Led DM study setup including protocol review, annotated CRFs, and DVS/LVS validation prior to database build and UAT.

  • Executed UAT for eCOA and EDC databases across 60+ studies including edit check validation and rule verification.

  • Tested 100+ edit checks per study and coordinated defect resolution cycles within quality timelines.

  • Performed database updates and data cleaning for 30+ studies ensuring audit trail compliance.

  • Coordinated cross-functional validation updates and ensured 100% on-time delivery with zero critical failures.

Cytespace

Clinical Data Coordinator Intern | 7 Months | India

  • Screened and managed 100+ patients ensuring consent and enrollment per protocol.

  • Managed CRF completion and SDV checks achieving 100% GCP compliance.

  • Resolved 200+ data queries with 95% resolution within timelines.

  • Supported 4+ monitoring visits and audits with zero inspection findings.

  • Updated CTMS records for 50+ participants improving tracking accuracy.

Certifications

Certified Food Safety HACCP Manager

Verified International Academic Qualifications

WES

SOP Writing Training

eHACCP.org

Good Clinical Practice (GCP)

NIDA Clinical Trials Network

Certified Clinical Research Professional (CCRP®)

SOCRA

Projects

Clinical Database Validation & UAT Execution Project

ICON PLC

Clinical Validation Analyst

Skills Used

  • EDC Validation, UAT Testing, DVS Review, Edit Check Testing, Data Cleaning, Regulatory Compliance

Key Roles

  • Executed end-to-end validation cycles for 60+ clinical studies.

  • Performed detailed edit check testing (100+ per study) ensuring protocol compliance.

  • Documented defects and coordinated retesting cycles with programming teams.

  • Conducted SDV checks and query verification prior to database lock.

  • Ensured 100% on-time validation delivery with zero critical findings.

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