Test Engineer Software

SRIVIDYA KOGANTI

Chester Springs, Pennsylvania **425 903-***-**** ************@*****.*** www.linkedin.com/in/srividya-koganti-5526911a

SUMMARY

Detail-oriented and results-driven Validation/ Data Quality Analyst with 10+ years of experience in clinical trial software testing, validation, and quality assurance across IRT, IWRS, eCOA, and eClinRO platforms. Proven ability to ensure software quality with a focus on patient safety, data integrity, and regulatory compliance (21 CFR Part 11, GAMP 5, GxP). Skilled in executing risk-based validation strategies, writing and executing test scripts (IQ, OQ, UAT), and supporting end-to-end SDLC documentation. Adept at communicating cross-functionally, leading validation efforts, and ensuring audit readiness.

Test Plan Development & Execution (IQ/OQ/UAT) Requirements Traceability & Protocol Alignment Risk-Based Testing Change Control GxP Compliance SQL & Data Validation Defect Management Project Management Agile, Scrum, and Waterfall Methodology SDLC & STLC Documentation Regulatory Audit Support SOP Adherence Team Collaboration Effective Communication Team Leadership Analytical Skills Debugging Troubleshooting Process Improvement Reporting Data Quality Detail-oriented Effective Prioritization Time Management Organizational Skills Data Exports

TECHNICAL SKILLS

Testing Tools: X-Ray Test Management Tool, Microsoft Test Manager, Automation Test Manager

Defect Tracking Tools: Assembla, Bugzilla, VSO, Jira

Project Management Tools: Jira, Team Foundation Server, Visual Studio Team Services

Computer Skills: Microsoft Word, Excel, PowerPoint, Visio, Outlook

Web Technologies: HTML, XML, VB Script, CSS

Languages: C, SQL, PL / SQL, HTML, JavaScript

Databases: MS SQL Server 2019 / 2008 / 2005, Oracle 10g / 9i,

Front-End Tools: SQL*Plus, Toad, SQL Enterprise Manager, SQL Profiler, SQL Query Analyzer, SQL Server Management Studio

HIGHLIGHTS

Wrote SQL queries, using SQL server to validate data during testing.

Performed GUI testing, functional and system testing, integration testing, function flow testing, load testing, automation of GUI testing, user acceptance testing (UAT), regression testing, end-end testing, front-end testing, black box testing, and database testing.

Tested Windows, web, and mobile applications.

Designed, developed, and executed test plans, test scenarios, and test cases for web-based and client and server applications.

Performed system integration and end-to-end and user acceptance testing for data services.

Used Jira, Assembla, MTM, and VSO Tool for defect management.

Generated reports, using Assembla and VSO tool, based on status of defect, test case, and test script.

Prepared test environment by creating robust test data and preparing baseline documents.

Developed clear documentation for all test results to validate with client or business.

Prepared QC report for test execution and defects daily.

Coordinated testing activity with development team.

Demonstrated comprehensive understanding of QA standards, flows, methodologies, procedures, and documentation.

Implemented complex functional tests that required understanding of application logic and excellent problem analysis and bug reporting.

I analyzed and solved complex problems.

EXPERIENCE

SIGNANT HEALTH, Blue Bell, Pennsylvania

Senior Software Test Engineer/ Validation Analyst, 2019-2025

Managed aspects of in-house testing documentation. Executed tests for all technology platforms. Led testing efforts on assigned projects in pod. Reviewed test cases and test scripts for quality and coverage. Supported user acceptance testing. Rater Station, an enhanced type of electronic Clinician-Reported Outcome (eClinRO) designed to improve interview quality while reducing administration and scoring errors.

Led the validation of clinical trial software platforms with a strong focus on patient safety, protocol adherence, and regulatory compliance (21 CFR Part 11, GAMP 5, GxP).

Developed and maintained validation documentation including traceability matrices, IQ/OQ/UAT scripts, and SOP-compliant reports.

Conducted cross-platform (web and mobile) testing for eCOA and Rater Station systems, ensuring functional accuracy and clinician usability.

Performed qualification testing on section builds and form designs to confirm correct configuration and behavior.

Identified, logged, and resolved software defects by collaborating with development teams and providing clear objective evidence.

Executed risk-based validation and managed change control testing, ensuring efficient coverage of protocol-specific requirements and optimizing testing resources and improving defect detection.

Participated in internal and client audit preparation, providing validation artifacts and addressing compliance inquiries.

Supported unit testing strategy development and partnered with engineers to provide early-phase feedback during development.

Facilitated review cycles and secured stakeholder approval for all validation deliverables.

Mentored new QA and validation team members on tools, procedures, and documentation standards.

Estimated effort, prioritized testing tasks, and maintained productivity across multiple concurrent studies under tight timelines.

Designed and executed comprehensive test cases; tracked and communicated test progress and defect resolution across cross-functional teams.

Championed continuous improvement by identifying opportunities to enhance testing accuracy, process efficiency, and compliance.

Provided post-deployment support and contributed to QA initiatives for platform enhancements and internal process improvements.

Regularly communicated status, risks, and blockers in Agile stand-ups and project team meetings.

Developed and executed validation strategies for data reports, exports, and end-of-study deliverables to ensure accuracy and compliance with clinical trial protocols.

Validated data mapping and export specifications, performing both positive and negative test cases for comprehensive coverage.

Verified and resolved data clarification requests in collaboration with data management teams.

Proofread requirements and specifications for clarity, accuracy, and consistency with protocol documentation.

Used SQL Server Management Studio to write and execute queries for backend data validation and mapping verification.

Logged and tracked defects in Jira, working with developers to ensure timely resolution.

Created and maintained test data sets to simulate real-world clinical scenarios for validation purposes.

Collaborated with cross-functional teams, including data managers, business analysts, and developers—to clarify requirements and address functional gaps.

Delivered detailed QA reports and defect status updates during Agile stand-ups and stakeholder meetings.

ALMAC GROUP, Lansdale, Pennsylvania

Software Test Analyst II, 2017-2018

Reviewed clinical study requirements and developed risk-based test cases to validate eClinical platforms, including IVRS/IWRS/IXRS systems. Performed manual and automated system, functional, regression, and performance testing to ensure accuracy and compliance. Validated core trial functionalities such as patient randomization, visit scheduling, and drug accountability, along with study-specific customizations. Also tested integrated components like ePRO and web-based drug reconciliation to ensure data integrity and protocol adherence across web and voice channels. Analyzed core IXRS (IWR/IVR) system functionality to understand baseline performance and assess risks introduced by study-specific customizations.

Planned, executed, and documented manual and automated validation testing for clinical study builds, ensuring accuracy and regulatory alignment.

Developed and executed comprehensive test cases—covering positive and negative scenarios—aligned with clinical protocols and user requirements.

Estimated testing efforts for new features and change requests, providing accurate forecasts and timelines to project stakeholders.

Ensured end-to-end traceability by linking test cases directly to user requirements and change controls for audit readiness.

Leveraged automation tools to accelerate regression cycles and improve testing efficiency.

Applied structured, risk-based validation methodologies to optimize test coverage and resource allocation.

Executed automated test scripts and validated outputs with objective evidence to meet acceptance criteria.

Utilized Microsoft Test Manager and TFS to manage validation artifacts, defects, and testing workflows across multiple releases.

Documented and reproduced defects, tracked resolution progress, and escalated high-priority issues when needed.

Coordinated testing timelines, test environment availability, and cross-functional resources for efficient execution.

Validated clinical trial systems across web (IWR), voice (IVR), and desktop interfaces.

Reviewed and verified randomization specifications and internally generated dummy kits for protocol compliance.

Used Octopus Deploy for code promotion in test and UAT environments, ensuring seamless delivery.

Created robust test data for internal and sponsor-specific validation across test and IUAT phases.

Validated critical clinical trial processes such as subject randomization, kit assignment, inventory tracking, and protocol compliance.

Collaborated with cross-functional teams—including PMs, developers, and validation leads—to clarify requirements and resolve functional gaps.

Conducted root cause analyses and supported corrective action planning for recurring issues.

Oversaw completion of test deliverables and maintained audit-ready documentation packages.

Supported manual and automated regression testing across multiple releases and iterations to ensure quality of updated builds.

YPRIME, Malvern, Pennsylvania

Validation Analyst, 2012-2017

Ensured the functionality and compliance of clinical trial software with a strong focus on patient safety and data integrity. Verified that all requirements were clear, testable, and aligned with clinical trial protocols. Validated both core and study-specific functionalities within IWR (web-based) and eCOA platforms, built on a platform-independent system supporting unified web and mobile access. These platforms streamlined trial management by automating key workflows such as clinical supply tracking and patient interactions, with customizations tailored to specific study needs.

Reviewed study-specific requirements and design documentation to ensure alignment with clinical trial protocols and sponsor expectations.

Analyzed business and system requirement documents (SRDs) to develop traceability matrices, linking test cases to requirements per SOPs.

Conducted risk assessments and developed risk-based validation plans, including change controls, in accordance with protocol and compliance needs.

Authored detailed functional test plans and scenario-based test scripts for IWR systems and custom clinical modules.

Performed manual testing of study-specific functionalities and validated outcomes against requirements and design specifications.

Used SQL Server Management Studio to verify backend data; wrote and executed complex SQL queries, stored procedures, and triggers to confirm data integrity.

Conducted functional, regression, black box, and end-to-end testing, including validation of backend processes and system integration points.

Executed positive and negative test scenarios to ensure robustness and correctness of study configurations.

Created and maintained test data reflective of protocol-specific logic to simulate real-world clinical scenarios.

Validated kit configurations and randomization logic using dummy kit lists and manual verification methods.

Participated in validation of mobile applications (iOS/Android) used for clinical data capture, including backend sync validation.

Conducted switch shake-out and regression testing prior to QA/UAT promotions to ensure environment stability.

Supported User Acceptance Testing (UAT) by preparing environments, creating test data, and assisting stakeholders during testing cycles.

Logged and tracked defects using tools such as Assembla and Microsoft Visual Studio (VSO); collaborated with development to ensure timely resolution.

Delivered daily defect updates and testing progress in Agile scrum meetings and compiled Quality Control (QC) reports for stakeholders.

Collaborated closely with project managers, validation leads, business analysts, and developers to refine test coverage and ensure requirement clarity.

Validated core clinical trial features including patient randomization, inventory management, drug accountability, reconciliation, and reporting modules.

Participated in data transfer and system integration testing, ensuring seamless flow and integrity across platforms.

ADDITIONAL EXPERIENCE

YPRIME, Malvern, Pennsylvania, Junior Business Analyst, 2010-2011. Translated high-level business and user requirements into detailed functional requirement specifications. I analyzed business requirements and prepared test scenarios and test data for testing purposes. Tested BusinessObjects XI 3.0 reports and validated values as per user requirements, using IMPACT application. I wrote several SQL queries, using Toad for validating BO reports with backend data. Involved in testing BO reports during service pack upgrades. Conducted test case reviews to ensure scenarios accurately captured business functionality.

EDUCATION

UNIVERSITY OF TEXAS, Tyler, Texas, Master of Science

JAWAHARLAL NEHRU TECHNOLOGY UNIVERSITY, Hyderabad, India, Bachelor of Engineering, Electronics and Communications Engineering

CERTIFICATIONS

Microsoft Certified Technology Specialist (MCTS), SQL Server 2008, Business Intelligence Development

Certified SAFe 5 Practitioner, Scaled Agile, Inc.

Contact this candidate