Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

SURESH BABU N

Bengaluru

Summary

Certified Clinical Data Coordinator with nearly 3 years of experience in global clinical trial data management. Demonstrates expertise in managing high-quality datasets across diverse therapeutic areas, with a consistent track record of precision, seamless vendor coordination, and successful database lock delivery. Proficient in platforms like RAVE EDC and Veeva Vault, with deep knowledge of CDISC standards. Recognized for excellence in respiratory studies and bone therapeutics, and known for attention to detail, collaboration, and process optimization.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Clinical Data Coordinator I

ICON Plc
Bengaluru
10.2023 - Current
  • Hands-on experience across Start-Up (CPPC), Conduct, and Closeout phases of clinical data management within the RAVE and Veeva Vault environment, contributing to multiple studies
  • Managed clinical trial data with precision and compliance, adhering to global data management plans and standardized processes to detect errors and implausible data
  • Led User Acceptance Testing (UAT), co-authored test scripts, and supported validation of manual and reconciliation listings
  • Assisted in reconciling data from ECG, PFT, eDiary, IRT, and Batch uploader for Central Lab, ensuring high data accuracy and operational efficiency
  • Acted as primary point of contact for two vendor reconciliations, resolving issues and enabling smooth coordination
  • Maintained effective communication with Clinical Trial Leads (CTLs) and vendors, offering strategic insights for resolving data-related challenges
  • Reviewed and corrected non-conformant data and non-ASCII issues to uphold compliance and quality standards
  • Conducted comprehensive reviews of Data Management (DM) listings, including standard and study-specific listings
  • Participated in closeout activities such as data locking/freezing, archiving, and managing site closure checklists
  • Achieved Database Lock (DBL) for conducted studies; meticulously archived trial documentation in Trial Master File (TMF) and received Inspire Award recognition for excellence
  • Strengthened data cleaning efforts by proactively reviewing 5+ Pinnacle 21 dataset
  • Demonstrated teamwork and technical expertise on Respiratory based therapeutic area study by successfully delivering the Study Database Soft Lock, twice.

Assistant Clinical Data Coordinator

ICON Plc
Bengaluru
10.2022 - 10.2023
  • Managed clinical trial data using Rave database, ensuring accuracy and compliance.
  • Proficient in discrepancy management, swiftly identifying and resolving data discrepancies to maintain data integrity.
  • Reviewed standard and study-specific listings, ensuring data quality and adherence to protocol requirements.

Education

MSc - Microbiology

JSS Academy of Higher Education & Research
06-2022

Skills

  • RAVE
  • Veeva Vault
  • CCDA Certified
  • Pinnacle 21
  • Query Management
  • ECOA/ePRO
  • External Data Reconciliation
  • Test script writing
  • UAT
  • Startup/Conduct/Closeout
  • Good Clinical Practice
  • Attention to Detail
  • Communication
  • Teamwork
  • Strong organizational and time management abilities

Certification

  • Certified Clinical Data Associate – SCDM (Sep 2024)
  • ICON Biometrics Academy – ICON Plc (Oct 2022)
  • ICON Inspire Award Recipient – (Jun 2023, Aug 2024)

Timeline

Clinical Data Coordinator I

ICON Plc
10.2023 - Current

Assistant Clinical Data Coordinator

ICON Plc
10.2022 - 10.2023

MSc - Microbiology

JSS Academy of Higher Education & Research

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SURESH BABU N