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.
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.
Sr. Software Developer/Manager, OperationsJune 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 developerFebruary 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.
LinkedIn Assessment :
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