Athira Suresh

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Athira Suresh

Clinical Data Management Specialist

Certified Clinical Research Professional with 3+ years of experience in clinical data management, specializing in database validation, discrepancy resolution, and regulatory compliance. Experienced in managing multi-study validation cycles and ensuring data integrity across global clinical trials.
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3

Years of experience

Athira

About Me

Clinical Data Management Specialist with experience in database validation, SDV, CRF review, and discrepancy resolution across oncology, hematology, and advanced therapy studies. Proven ability to manage simultaneous clinical trials, execute UAT for EDC and eCOA systems, maintain regulatory compliance (ICH-GCP, FDA 21 CFR Part 11), and ensure inspection readiness. Skilled in Medidata Rave, Oracle Clinical, REDCap, CTMS, Excel trackers, and Power BI.
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My expert
areas

Expert in clinical database validation, SDV, discrepancy management, regulatory compliance, and multi-study coordination across complex therapeutic areas.

Skills

Clinical Data Validation & SDV

Discrepancy & Query Resolution

EDC & eCOA User Acceptance Testing

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

Database Setup & Edit Check Testing

Clinical Systems (Medidata Rave, Oracle Clinical, REDCap, CTMS)

  • 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 & Data Cleaning Project

ICON PLC

Clinical Validation Analyst

Skills Used

  • Medidata Rave, Oracle Clinical, SDV, Edit Check Testing, UAT, Discrepancy Resolution, Regulatory Compliance

Key Roles

  • Led database validation cycles for 60+ clinical studies

  • Performed edit check testing and documented system defects

  • Conducted SDV and data cleaning ensuring protocol adherence

  • Coordinated with programming and DM teams for timely database lock

  • Maintained audit trails and ensured compliance with ICH-GCP and FDA requirements

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