Athira Suresh
Clinical Data Management Specialist
Follow me:
3
Years of experience
Athira
About Me
My expert
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)
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60
Studies Validated (+) -
100
Edit Checks Tested (Per Study) -
30
Studies Supported (Data Cleaning & Updates) -
100
Patients Screened & Managed (+)
Education
Experience
Iron Mountain
Imaging Specialist | March 2026 – Present
- Processed document imaging batches with 100% record traceability, maintaining indexed archival queues for compliance validation tasks.
- Validated 100+ scanned records for completeness, reconciling metadata discrepancies across controlled audit workflows.
- Rectified classification inconsistencies with 98% indexing precision, supporting retrieval verification and compliance review cycles.
- Streamlined imaging workflows with 20% faster record processing while maintaining controlled document retention standards.
ICON PLC
Clinical Validation Analyst I | 3 Years | India
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Led DM study setup including protocol review, annotated CRFs, and DVS/LVS validation prior to database build and UAT.
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Executed UAT for eCOA and EDC databases across 60+ studies including edit check validation and rule verification.
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Tested 100+ edit checks per study and coordinated defect resolution cycles within quality timelines.
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Performed database updates and data cleaning for 30+ studies ensuring audit trail compliance.
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Coordinated cross-functional validation updates and ensured 100% on-time delivery with zero critical failures.
Cytespace
Clinical Data Coordinator Intern | 7 Months | India
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Screened and managed 100+ patients ensuring consent and enrollment per protocol.
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Managed CRF completion and SDV checks achieving 100% GCP compliance.
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Resolved 200+ data queries with 95% resolution within timelines.
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Supported 4+ monitoring visits and audits with zero inspection findings.
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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
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Medidata Rave, Oracle Clinical, SDV, Edit Check Testing, UAT, Discrepancy Resolution, Regulatory Compliance
Key Roles
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Led database validation cycles for 60+ clinical studies
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Performed edit check testing and documented system defects
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Conducted SDV and data cleaning ensuring protocol adherence
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Coordinated with programming and DM teams for timely database lock
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Maintained audit trails and ensured compliance with ICH-GCP and FDA requirements
