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Summary

 11 years of progressive experience in Clinical Trial software product development, software validation and operations.  Experience in software development life cycle (SDLC): analysis of requirements, design, development, test and documentation.  Specialized in Clinical Trial domain software development which includes Electronic Data Capture (EDC), IWRS, IVR, CTMS,AERS, Medical Coding applications.  Experience in preparing BRS, URS-FRS, Design Specification Documents, SOPs, Requirement Traceability Matrix etc.  Experience in preparing and executing SIT and UAT Script for validation of Clinical Trial Software.  Experience in Software validation - UT, SIT, UAT.  Experience in assisting Clinical Data Management team to build clinical database with CRF creation, Edit check implementation and validation.  Experience in developing 21 CFR Part 11 compliant software.  Experience in interacting with end user starts from requirement gathering to final product demo to end user.  Builds strong teams, implements organizational process improvements that ensure the on-budget and on-time delivery of software application with a philosophy of working to exceed customer expectation.  Excellent ability to read code and suggest changes to make the finished project glitch free.  Experience in Web based, and Client/Server application design & development using Java, JSP, Servlets, MS SQL, Java Script, Struts, Hibernate, Spring, JSF and J2EE Architecture.

Experiences

Current Experience

  • Team Lead/Manager, Operations
    Since November 2013
     Lead a team of software developers for Clinical Research Organization client.  Involved in interaction with end user starts from requirement gathering to final product demo to end user.  Assigned coding tasks to various team members and ensured team members stayed on task.  Directed team meetings to check on progress and plan code direction.  Attended development work prioritization meetings and interact with end user.  Ensured the programming team developed high-quality working applications to clients.  Monitored all aspects of applications being developed to ensure they met quality standards.  Actively involved in development of different types of eCRFs, Edit check functionality, Query management tool for EDC application.  Assisted Project Manager during creation of project plan, resource allocation, project tracking, product documentation etc.  Involved in code review phase.  Responsible for preparing BRS, URS-FRS, Design Specification Documents, SOPs, Requirement Traceability Matrix etc.  Responsible for preparing and executing SIT and UAT Script for validation of Clinical Trial Software.  Active role in Software validation - UT, SIT, UAT.

Past Experience

  • Sr. Software Developer/Manager, Operations
    June 2010 --- October 2013
     Involved in requirement gathering with end user.  Converted business requirement in to functional requirement specification.  Created system design specification.  Written well designed code in compliance with recognized industry standard practices.  Prepared unit test plan and scripts and involved in unit testing (manual).  Prepared system integration test plan and scripts and involved in system integration testing (manual).  Provided proof of concept demo to end user and acquired enhancement requirements.  Closely worked with junior developers during system development.  Assisted end user during User acceptance testing.  Responsible for product release to end user.  Provided training to end user on system.  Provided technical support to end user when system is in production.  Keep track of bugs during production and worked with developers to keep track of resolutions

  • System developer
    February 2005 --- May 2010
     Active participation and contribution in development and requirement analyzing.  Responsible for developing IWRS,CTMS application  Responsible for developing study budgeting, site budgeting and granting functionality in trial management application.  Integrate software components into a fully functional software system.  Assisting Sr. Developers in preparing design specification, test plan and test cases.  Testing software to ensure the code is correct, fixing ('debugging') errors where they occur, and rerunning and rechecking the program until it produces the correct results  Working with trainers and technical writers to develop user support materials.

Knowledge

LinkedIn Assessment :
SQLSoftware DevelopmentSDLCRequirements AnalysisSoftware Project ManagementJavaTechnical SupportHibernateSpring FrameworkJSFPrimefacesRichFacesTechnical LeadershipVisual SVNClinical Data ManagementClinical trialsGood Clinical Practice (GCP)Microsoft SQL Server

Education

  • Bachelor of Engineering in Information Science from Visvesvaraya Technological University in 2004
  • Diploma in Computer Science from Shree Vidyadhiraj Polytechnic in 2000

Training and Certification

  • OCPJP Certification

Area / Region

Bangalore, Karnataka, India

Others

Driving License
  • No