Vinotha T
Chennai
Summary
"Well done is better than well said" - An Independent and a Self motivated graduate basically a Developer by Profession and an Optimist by Possession.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Clinical Data Management Specialist/Programmer
Cognizant
07.2021 - Current
- Managed the migration of clinical studies from Oracle LSH to Veeva CDB, ensuring smooth data transfer and system integration.
- Handled all clinical data management tasks for BAYER Pharmaceuticals using Oracle LSH Data Hub and Oracle DMW, overseeing data processing and validation.
- Worked on the creation of study setups, including specification updates and peer reviews, ensuring adherence to study protocols.
- Ensured compliance with ICH-GCP guidelines and Good Clinical Practices (GCP), with all relevant SOPs in place.
- Managed external and third-party data sources, and performed unblinding and blinding of clinical studies as needed.
- Acted as a liaison between clients and internal teams, accurately understanding client requirements and delivering high-integrity data.
- Applied MEDDRA and WHO coding for clinical study domains, maintaining consistency and accuracy in data handling.
- Developed expertise in building checks, listings, and reconciliation tasks within Veeva CDB.
- More than a year of experience in R&D and actively working on the clinical data management
- Working as a Clinical study programmer holding experience in study development and support activities involving development, design and testing of metadata and data warehousing in ORACLE LSH (Life Science Data Hub) and Data Management Workbench (DMW)
- Expertise in fetching data from RAVE(EDC) and other external database sources to DMW/LSH servers through various adaptors
- Experience in data transformation and data load activities Using PL/SQL packages
- Create/Update Data Transfer Specification (DTS) along with external data transfer specification for external data as per Study design
- Involved in creating application areas, work area, extracting the data via DataMart, Loading the data via Load sets, Visualization the data via Business areas as well as writing PLSQL packages to accommodate client requirements for data processing, data validation and data publishing
- Working on the Data release and Database lock and providing Impact analysis on Post Production changes
Data Management Specialist
Pfizer
12.2020 - 06.2021
- Company Overview: Life Science domain base with a good knowledge on Revenue Management and Clinical data management
- Worked on the enhancement of the interfaces and deploying it to the production database
- Actively worked on analyzing the PL/SQL packages and creating Unix Shell scripting to call these packages
- Prepared the deployment guides, property files, documents for the deployment through Dimension tool
- System testing and integration testing are done without fail thereby increasing the quality of the code without any discrepancies
- Prepared Technical design and Functional Design documents as per the change request
- Performance testing and modified the production code if required
- Life Science domain base with a good knowledge on Revenue Management and Clinical data management
Application Development Analyst
Accenture
04.2017 - 06.2021
- Oracle PL/SQL developer with a good knowledge in Analyzing, Designing and Implementation of Business Application using Oracle RDBMS
- Created and modified PL/SQL packages and procedures for data extraction
- Enhancing the cursors and exception handlers to retrieve data and capture the errors
- Wrote Unix shell script to process the files on a daily basis like extracting the data as per the date, zipping the contents and emailing them to the corresponding DL's
- Worked on Support projects and have contributed in Incident Management and Root cause Analysis area's
- Tools/Platform worked on: Netezza, Jira, Oracle LSH, EDC, Phlexview, Medidata Rave, SQL developer, Veeva, Oracle DMW
Education
Electronic and Communication Engineering -
SRI KRISHNA COLLEGE OF ENGINEERING AND TECHNOLOGY
04.2017
Skills
- Veeva CDB
- SQL, PL/SQL
- Medidata Rave
- Oracle LSH
- Oracle DMW
- Unix Shell Scripting
Certification
- Oracle Cloud Fundamentals
- Oracle SQL Certified Associate
- Microsoft Azure Fundamentals
Languages
English
Tamil
Hobbies and Interests
- Travelling
- Swimming
- Dancing
Timeline
Clinical Data Management Specialist/Programmer
Cognizant
07.2021 - Current
Data Management Specialist
Pfizer
12.2020 - 06.2021
Application Development Analyst
Accenture
04.2017 - 06.2021
Electronic and Communication Engineering -
SRI KRISHNA COLLEGE OF ENGINEERING AND TECHNOLOGY
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