Summary
Overview
Work History
Education
Skills
Websites
Core Areas Of Expertise
Accomplishments
Timeline
Generic
Sivakumar AY

Sivakumar AY

Bengaluru

Summary

Clinical data management professional with more than 6 years of experience. Involved in data management activities for clinical trials in the start-up, conduct, and close-out phases.

Overview

6
6
years of professional experience

Work History

Clinical Data Specialist

IQVIA
Bengaluru
01.2022 - Current
  • Managed team of 8+ in oncology therapeutic area phase studies.
  • Executed query management, data review, and validation using SAS Edit checks.
  • Reconciled internal and external data including IPDs, IVRS and laboratory results (Missing labs).
  • Supported study start-up activities, including User Acceptance Testing and eCRF guidelines.
  • Participated in study close-out processes such as database lock and e-archival.
  • Conducted quality control on clinical data management activities per SOPs.
  • Mentored new reviewers in understanding processes and enhancing performance.
  • Regularly updated study metrics to support team members with data management tasks.

Associate Clinical Data Coordinator

IQVIA
Bengaluru
07.2020 - 12.2021
  • Managed and resolved clinical data queries in accordance with the guidelines set forth in the Data Management Plan (DMP) and Data Validation Plan.
  • Conducted manual listings reviews, identifying, and addressing inactivated pages, non-conformant data, duplicate pages, unsubmitted data points, and unsubmitted forecasted pages using various data listing reports and SAS listings.
  • Reconciled external vendor data, including Central Lab data, ensuring accuracy and consistency.
  • Performed Important Protocol Deviation (IPD) reconciliation using Clinical Trial Management System (CTMS).
  • Conducted comprehensive reviews of Line Listing Reports (LLR) and Laboratory Normal Ranges (LNR) issue logs, updating lab issues, and coordinating with RCTMs and LNR Coordinators for resolution.
  • Updated and managed communication logs (e-LOG) for query resolution and tracked study metrics monthly and during study milestones.
  • Utilized TIBCO Spotfire for SAS checks allocation and comments review, ensuring efficient data management.
  • Led various levels of quality reviews, database lock activities, snapshot activities, and maintained errata logs.
  • Mentored and trained team members, ensuring adherence to quality control procedures and standard operating procedures (SOPs).
  • Attended project team meetings, providing feedback to the group manager on challenges, issues, and successes.

Trainee Clinical Data Coordinator

IQVIA
Bengaluru
07.2019 - 06.2020
  • Gained foundational knowledge in various clinical data management tasks, including review of SAS listings and basic quality control procedures.
  • Participated in risk-based study activities and segment reviews, developing a keen understanding of clinical data processes.
  • Trained on essential study start-up activities, including User Acceptance Testing (UAT), eCRF completion guidelines, and DMP review.
  • Assisted in updating and managing communication logs (e-LOG) for resolving queries.
  • Supported team members in performing data reconciliation tasks and manual listings reviews.
  • Demonstrated initiative in learning and applying standard operating procedures (SOPs) to all tasks.

Education

Master of Science - Bio-Technology

Reva University
Bangalore, Karnataka
05-2019

Skills

  • Clinical database
  • EDC system
  • Medidata Rave
  • Medical affairs
  • Medidata Classic Rave
  • Microsoft Office
  • Data reconciliation
  • Query management
  • Database validation
  • Problem solving
  • Team collaboration
  • Adaptive learning capacity
  • Decision-making capacity
  • Advanced Excel
  • Vendor management
  • Clinical data management

Websites

Core Areas Of Expertise

  • Clinical database/ EDC system such as Medidata Rave/Medical Affairs/Medidata Classic Rave.
  • CDISC, CDASH standards, ICH-GCP and GCDMP.
  • Advance Excel, Customer Acquisition, Microsoft Office.

Accomplishments

  • 4 Bronze Awards from IQVIA (04/2022 - Present) for achieving 4 database locks for 2 different projects in the conduct and close-out phases
  • 3 Ovation Awards from IQVIA (Jan 2020 to Mar 2022) for excellent work delivered in 3 projects with good quality

Timeline

Clinical Data Specialist

IQVIA
01.2022 - Current

Associate Clinical Data Coordinator

IQVIA
07.2020 - 12.2021

Trainee Clinical Data Coordinator

IQVIA
07.2019 - 06.2020

Master of Science - Bio-Technology

Reva University

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Sivakumar AY