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, Karnataka05-2019
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