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Bhoomika Soumya Sindhu V.

Bhoomika Soumya Sindhu V.

Process Engineer

India flagBangalore, India

Key Skills

Software

Internal/Proprietary Tooling

Top Subject Matter

Clinical Trials Data
Clinical Trials and Vendor Data Management
Clinical Database Management Systems

Top Data Types

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DocumentDocument

Top Task Types

ClassificationClassification
Data CollectionData Collection

Freelancer Overview

Data Review and Annotation. Brings 4+ years of professional experience across complex professional workflows, research, and quality-focused execution. Core strengths include Medidata RAVE and InForm Database. Education includes Master of Medical Biotechnology, Manipal Academy of Higher Education, Manipal (2018) and Bachelor of Biotechnology, Christ University, Bengaluru (2016).

Labeling Experience

External Data Acquisition Operations Analyst - Data Collection & UAT

TextTextData CollectionData Collection

As an External Data Acquisition Operations Analyst at Accenture, I managed the delivery and quality of external data needs throughout the database design and build lifecycle. I participated in developing data transfer specifications and was responsible for supporting UAT activities for various vendor datasets. My role was crucial in ensuring compliance with standard business processes and the accuracy of clinical trial data for AI/ML readiness. • Created and reviewed data transfer specifications for external datasets. • Supported in-life activities and user acceptance testing for vendor files. • Managed data consistency across CTMS, EDC, and InForm databases. • Ensured external data was production-ready for clinical research and AI systems.

2019 - Present

Assoc EDS Reviewer - Data Review and Annotation

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As an Assoc EDS Reviewer at LabCorp Drug Development, I reviewed electronic vendor data to ensure it met protocol parameters and accurate field population. My duties included performing user acceptance testing (UAT) for electronic data capture (EDC) systems and resolving discrepancies in patient datasets. I supported the validation review process for electronically transferred clinical data and maintained the accuracy of lab ranges in data capture modules. • Performed regular UAT on Medidata RAVE database. • Reviewed data edit checks and managed query resolution processes. • Verified data accuracy for clinical trial patient results. • Communicated with study teams regarding data transfer and point issues.

2021 - 2022

Validation Testing Analyst - UAT and Annotation Quality

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As a Validation Testing Analyst at Accenture, I created and maintained user acceptance testing (UAT) protocols for EDC systems to ensure suitability and accuracy for clinical data annotation and management. I led standardization efforts and supported the quality assurance of Electronic Data Capture applications, facilitating team trainings in annotation protocols. My work ensured efficient and high-quality EDC environments for downstream AI and analytics tasks. • Conducted team supervision and training on UAT and annotation. • Developed standardized protocols for the evaluation of clinical data entry. • Performed cross-functional quality audits on annotation workflows. • Supported EDC managers in enhancing EDC system efficiency and accuracy.

2018 - 2019

Education

M

Manipal Academy of Higher Education, Manipal

Master of Science, Medical Biotechnology

Master of Science
2016 - 2018
C

Christ University, Bengaluru

Bachelor of Science, Biotechnology

Bachelor of Science
2013 - 2016

Work History

A

Accenture Solutions

External Data Acquisition Operations Analyst

Bangalore
2019 - Present
E

Eurofins IT Solutions India

Process Engineer

Bangalore
2022 - 2022