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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.  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 in 0000 Certification

Area / Region

Bangalore, Karnataka, India

Others

Driving License
  • No

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