Vishwadeep Hanshetti
Bengaluru
Summary
Results-driven professional with extensive experience at IQVIA, excelling in Clinical Data Management and effective communication. Proven track record in managing validation teams, enhancing project efficiency, and implementing quality management plans. Adept at fostering collaboration and driving process improvements, ensuring compliance and timely deliverables in clinical data environments.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Assoc Clinical DB Validation Manager
IQVIA
Bangalore
07.2021 - Current
- Managing SAS listings validation team, assigning study-related activities to enhance efficiency.
- Collaborated with functional managers to allocate resources for on-time project deliverables.
- Implemented proactive quality management plans across multiple projects to ensure standards.
- Tracked service performance and led initiatives to identify issues and execute corrective actions.
- Pursued process improvement opportunities, collaborating with team to drive change across projects.
- Ensured prompt follow-up and resolution of compliance issues to maintain standards.
- Served as Subject Matter Expert for validation group, providing guidance and expertise.
- Trained and mentored Testing Team Members, fostering skill development and knowledge sharing.
Assoc Validation Team Lead
IQVIA
Bangalore
02.2015 - 06.2021
- Executed validation activities on data review listings, data transfer, and vendor data import to support study configuration.
- Attended regular project meetings until completion of study validation.
- Took responsibility for creation of test plan document and development of test cases.
- Released testing documents to testing team for execution of testing activities.
- Reviewed specification document, providing input and escalating issues as necessary.
- Analyzed testing comments log after each cycle and shared findings with programmer.
- Documented all testing materials in eTMF promptly.
- Cultivated strong customer relationships to enhance collaboration.
SDTM QC Analyst
Accenture India
Bangalore
04.2013 - 01.2015
- Executed testing of SDTM mappings using SAS programming to support study creation.
- Compared data against SDTM mappings developed by mappers for accuracy validation.
- Documented and tracked defects during tests, contributing to resolution efforts.
- Entered status updates, defect information, and metrics for timely QC reporting.
- Compiled and organized documentation for QC Test Binders.
- Communicated issues to RAM management for escalation and participated in problem-solving meetings.
- Fostered strong collaboration with team members to enhance workflow.
- Maintained documentation in compliance with SOP requirements.
Clinical Database Tester
Accenture India
Bangalore
04.2011 - 03.2013
- Established and maintained Quality Control (QC) and User Acceptance Testing (UAT) procedures for electronic data capture systems and clinical databases.
- Coordinated QC efforts across departments to ensure standardization, efficiency, and quality.
- Executed quality assurance test scripts on new EDC trials and software applications.
- Trained QC/UAT analysts, CDTs, and CDS developers on established procedures.
- Tracked defects during testing phases and facilitated resolutions actively.
- Entered status updates, defect information, and metrics for timely QC reporting.
- Developed methodologies for test design, documentation, and results reporting.
- Validated trial application designs through rigorous testing and acceptance processes.
Reports Quality Control Analyst
Accenture India
Bangalore
04.2010 - 03.2011
- Executed QC testing to support study creation and configuration changes, including EDC user requirements and eCRFs.
- Performed quality control and software quality assurance tests on eCDM systems using INFORM tool.
- Recorded defects identified during testing and engaged in resolution efforts.
- Entered status updates, defect details, and metrics to ensure timely QC reporting.
- Completed and organized documentation for QC test binders.
- Communicated issues to QC management and participated in meetings to explore research options.
- Cultivated strong working relationships with team members to enhance collaboration.
- Maintained documentation in compliance with SOP requirements.
Education
Bachelor of Engineering - CSE
Visveswaraya Technology University
Karnataka01.2009
Skills
- Effective communication
- Team collaboration
- Quick learner
- Microsoft Excel
- INFORM Knowledge
- Imedidata (Rave) knowledge
- SQL programming
- Python programming
- Base SAS programming
- Power BI visualization
- Data analysis
Professional Summary
Clinical Data Management Professional with 15 years of experience in end-to-end database validation, including SDTM, data review listings, vendor data import, and custom reports. Proven leadership in managing validation teams and driving operational excellence. Skilled in EDC systems (Inform, Medidata RAVE), project management, and cross-functional collaboration.
Certification
- SAS Certified Base Programmer for SAS 9, 2014
- ISQT Certified Test Engineer, ISQT Training Institute, Completed Manual Testing.
Personal Information
- Father's Name: Gangadhar Hanshetti
- Date of Birth: 02/09/87
- Gender: Male
- Nationality: Indian
Languages
- English
- Kannada
- Hindi
Hobbies and Interests
- Music
- Cricket
Disclaimer
I hereby declare that all above given information is true as per my knowledge.
Timeline
Assoc Clinical DB Validation Manager
IQVIA
07.2021 - Current
Assoc Validation Team Lead
IQVIA
02.2015 - 06.2021
SDTM QC Analyst
Accenture India
04.2013 - 01.2015
Clinical Database Tester
Accenture India
04.2011 - 03.2013
Reports Quality Control Analyst
Accenture India
04.2010 - 03.2011
Bachelor of Engineering - CSE
Visveswaraya Technology University
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