Developer/RAVE Programmer (Study Design, Custom Function), Developer/RAVE Programmer

testing, implementation of windows and WPF using DevExpress tools and Microsoft
Technologies.
* I was working in QuintilesIMS Research India Pvt Ltd. Bangalore, as C# Rave Programmer in
CLINICAL DATA MANGEMENT domain for 2.5 year.
* Currently working Accenture India Pvt Ltd, Bangalore. As a C# Rave Programmer in CLINICAL
DATA MANGEMENT domain for 2.5 year.
* Having skills ranging from RAVE STUDY DESIGN (Study Building, e CRF Design, Edit Check
Building, Edit Check Testing), RAVE- CUSTOM FUNCTION DEVELOPMENT(Non-Modifiable,
Modifiable, Study specific, UNIT TESTING, QUALITY TESTING, MIGRATIONS.
* Expertise in developing Edit Checks, Custom Functions and Derivations for different
sponsors.
* Also I have been working around building internal application using windows and WPF
application.
* Experience in implementing Database Tables, Stored Procedures as per the user requirements
using SQL Server 2008.
* Experience in Electronic Data Capture (CDM) and Protocol Study Build knowledge as per 21
CFR Part 11 (Electronic Records and Electronic Signatures) and GCP's related to
Pharmaceuticals / Life Sciences / Biotech Industry.

Project 2:

Project Medidata Rave Study Design, Custom Function and Script Development
Environment Medidata Rave 5.6.4, Visual Studio 2010, C#.Net, MS SQL Server 2008
Role Developer/RAVE Programmer (Study Design, Custom Function)
Team Size 22
Description
Medidata provides the first electronic clinical data management (eCDM) product to include CDMS and
Electronic Data Capture (EDC) capabilities within single technology platform. Offering a full
package of functionality, including flexible tools and customized reports to streamline workflow,
our true "thin client" application is faster to learn, easier to use and more rapid to deploy. The
main aim of the project includes deployment of Edit Checks for Medidata Rave TM platform
application. This product is used for maintaining Clinical Trials under the health care domain. Edit
check is a specification for the functionality of one rule defined on a particular field of a form;
the work involves development of edit checks using stored procedures in MS-SQL Server - 2008
environment. The nature of the works could be based on production issue as well development of
Custom Function edit checks.

Project 3:

Project Medidata Rave Study Design, Custom Function and Script Development
Environment Medidata Rave 5.6.4, Visual Studio 2010, C#.Net, MS SQL Server 2008
Role Developer/RAVE Programmer (Study Design, Custom Function)
Team Size 20
Description
To provide innovative clinical research solutions that safely and efficiently improves quality of
life. Medidata Rave software supports compliance with Electronic Records/Electronic Signature
(ER/ES) requirements such as the US 21 CFR Part 11 and the MHLW ER/ES Regulation. The objective of
the Project is to Develop and QC eCRFs/Custom Edit Checks/Custom Functions based on the Requirements
provided for each study by client. Custom Edit Checks/Custom Functions defines the Business Logic
implemented on the eCRFs of a particular Study/Project of the Life Science Research Organizations.
The Development of Custom Edit Checks will be done using Stored Procedures/Programming code using C#
in Visual Studio Environment for 5.x Version.




Project 4:

Project DiReT(Dictionary Review Tool) for Global Library
Description DiReT tool which gives discrepancies between ALS and Control Terminology sheets with considering n
number of parameters in single click. And also which avoids huge time that was working manually.

Application Type Windows and WPF Application
Team Size 1
Language/IDE/Tools used VS-2010, .Net 4.0, C#, ADO .Net

Responsibilities & Contribution
* Understanding GL requirement and plan accordingly.
* Importing excel files and comparing each record with considering number of parameters.
* Keep in mind that time saving with existing process.
* Simplify as much as possible and build user friendly application.




Project 5:

Project Quick CF Edits Tool for Custom Function programmers.
Description
Quick CF Edit tool which gives simplified script for edit checks with minimum inputs in single
clicks. This tool creates edit check script which is similar to that creates through RAVE
architecture using Quick Edits. And this tool will take care of auto inactivation form, folder/forms
repeat numbers and standard action datapoaints.


Application Type Windows and WPF Application
Language/IDE/Tools used VS-2010, .Net 4.0, C#, ADO .Net,
Team Size 1
Responsibilities & Contribution
* Understanding CF requirement and plan accordingly.
* With minimum number of requirement the script has to generate.
* Considering time saving with existing process.
* Minimize the programmers error that occurs through wrong edit check script.




Responsibilities

* Analysis and Developing Clinical Study Build (eCRFs, Edit Checks, Custom Functions, RWS) using
Rave.
* Responsible for the Project deliveries from Offshore and coordinating with Clinical Study
Build team.
* Reporting Daily Status Report to Onsite Coordinator and Project Manager.
* Preparing periodical Delivery Plan, Timelines, Metrics, Best Practices and other related
documents.
* Review and Fix the UAT and PROD Issues related to the Custom Functions
* QC on eCRFs, Custom Edit Checks, Custom Functions.
* Experience in Electronic Data Capture (CDM) and Protocol Study Build knowledge as per 21 CFR
Part 11 Standard.
* Involved in the design and development of database. Writing stored procedures and functions.
* Developed DMP RECONCILATON REPORT of Study Specific checks for Clinical Study.
* Developed a report to display form, folder, Matrix, Custom-Function, Derivation, Restriction.
* Developed Edit Check Log Report, Enrolment Report, Audit Trial Report, Study Specific Report.