Vismaya TM
Bengaluru
Summary
Clinical Data Management professional with over 3 years of experience in all phases of data management, including EDC setup, eCRF design, and User Acceptance Testing. Proven track record in managing clinical trials across oncology and cardiology, ensuring data accuracy and compliance with regulatory standards. Expertise in data collection, validation, and project closeout, consistently delivering projects on time. Seeking opportunities to further develop skills and contribute to team success.
Overview
3
3
years of professional experience
1
1
Certification
Work History
Clinical Data Analyst
Fortrea (Formerly Labcorp Drug Development)
Bengaluru
10.2023 - Current
- Maintained compliance with Good Clinical Practice guidelines in all data management efforts.
- Completed essential trainings in a timely manner.
- Review and action queries on an ongoing basis, and update the database appropriately by Data Management Plans (DMP) and applicable standardized data management tasks, as assigned.
- Performed User Acceptance Testing based on validation plans for applicable systems.
- Generate, resolve, and track queries to address inconsistent data identified during data review activities, and apply proper modification/correction to the database.
- Created study-specific status reports/Metrics for management and client updates.
- Perform vendor data reconciliation (Lab, IRT, Safety).
- May develop, test databases, and edit specifications.
- Organize and participate in the Project Team meeting with the Sponsor and external teams.
Executive - Clinical Data Management
SyMetric(A Brand owned by Achiral Systems), Bengaluru
Bengaluru
02.2022 - 09.2023
- Executed EDC setup activities, including database design and programming of edit checks for projects.
- Performs User Acceptance Testing (UAT) for data entry screens, edits, and assigned data review listings, all different roles used in the study.
- Performed comprehensive data management tasks, including data listings review and cleaning.
- Discrepancy management of all the errors arising during data entry.
- Executed vendor reconciliations and Serious Adverse Event (SAE) assessments.
- Review, freeze, and/or lock data in accordance with Data Management documents for accuracy, completeness, consistency, and validity.
- Receives and enters lab normal ranges.
- Performs DM quality review and/or other internal QC checks, as required per applicable electronic data capture (EDC) systems.
- Participates in internal meetings and internal/external audits as required.
Education
Bachelor of Pharmacy -
National College of Pharmacy
Shivamogga, Karnataka11-2021
Skills
- Clinical Data Management
- Microsoft Office
- Multiple EDC platforms: Medidata Rave, Veeva, SyMetric CTP
- ICH-GCP
- Analytical thinking and problem solving
- eCRF Development
- Clinical data management
- Electronic data capture
- Data validation and reconciliation
- Query resolution
- User acceptance testing
- Excellent communication
Accomplishments
- Contributed to accomplishing DBL activities and DM metrics in tough timelines, and received appreciation from the Data Team Lead and management
- Played a vital role in identifying and resolving the issue by examining the data trends in critical deliverables, and received appreciation from higher management
- Received a Level 2 award in 2024 from Fortrea for working on four studies during their final lock with almost 100% quality
Certification
- PCI-registered Pharmacist
- NIDA Clinical Trials Network
Timeline
Clinical Data Analyst
Fortrea (Formerly Labcorp Drug Development)
10.2023 - Current
Executive - Clinical Data Management
SyMetric(A Brand owned by Achiral Systems), Bengaluru
02.2022 - 09.2023
Bachelor of Pharmacy -
National College of Pharmacy
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