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Project Manager Data Entry

Location:
Plano, TX
Posted:
July 08, 2016

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Resume:

PRAKASH BABU KOTI

acvl6u@r.postjobfree.com Mobile: 469-***-****

Profile Summary:

A dedicated assertive technology professional with over 12 years of experience working on various Health sciences and e- commerce projects, products, providing technical solutions to various customers.

Over 8.5 years of experience with strong knowledge in Health sciences domain working on Oracle InForm™, Central Designer™ and various other Oracle Health sciences products.

3.5 years of e-commerce domain experience working on developing web based applications.

Proficiency on Oracle Health Sciences Products, Oracle Argus safety system and Oracle database and well experienced in Patient data capturing and clinical database knowledge.

Involved in designing, developing and testing of clinical trials designed for Phase I, II and III using Oracle InForm™, Central Designer™, and Architect

Integrated InForm studies with various standard integration solutions like IVRS, IRT and LNMT.

Involved in migrating InForm studies and solutions integrated with the studies to latest versions

Involved in designing Phase IV / Post marketing studies using Oracle OutcomeLogix™.

Good communication and presentation skills, ability to meet critical targets, and Involved in on-site client trainings on Central Designer (Quintiles - Bangalore, TCS - Mumbai)

Good inter-personal skills, committed, result oriented, hard working with a quest and zeal to learn new technologies and tools Academic Background:

Bachelor’s in Computer Science from Andhra Loyola College, Vijayawada. Skill set:

Domains:

Health Sciences, e-commerce

Oracle Health Sciences Products:

InForm™ (v4.6.x to v6.x), Central Designer™ (1.1 to 2.1), Architect™, IVRS Standard solution, IRT, LNMT, DoD, Central Coding™, RDE, Oracle Argus Safety,

Programming Languages

C#, VB.NET, Java

Web Technology

Oracle APEX, ASP.NET v1.1, v2.0, v3.5, v4.0, XML, HTML, DHTML, ASP.Net Web API Client Scripting

JavaScript, VB Script, JQUERY

Microsoft Technologies

.NET Framework v1.1, v2.0, 3.0, 3.5, 4.0, WCF, MVC3, MVC4 Database

SQL Server 2005, Oracle11g

Reporting Tools

OBIEE 10g, BI Publisher 11g

Design Tools

UML, Microsoft Visio

Testing Tools

NUnit

Certifications and Achievements:

InForm™ Developer certification

Employee of the Quarter award for 2 times from Oracle

Received SPOT bonus reorganization award for 5 times from Oracle (Phase Forward)

Innovation Award from Oracle

Professional Experience:

Principal Technical Consultant

Castortek LLC May 2016 to till date

Product: Healthcare Meaningful Use Dashboard

Synopsis

Develop the Healthcare Meaningful Use Dashboard to display the Business metrics and measures of Stage1 and Stage 2 meaningful use. This dashboard will contain the pre-validated codes and configuration in order to calculate the metrics of meaningful use measures on relational and SAP database. This dashboard will required only installation part to hookup with the relational ETL Tables or via the Business Object Universes on top of SAP databases in order to minimize the efforts of healthcare and Medicare clients to develop the customized reports and dashboards to display 24 Measures of Meaningful Use. Principal Technical Consultant

Oracle Corporation January 2008 to April 2016

Product: InForm™ (v4.6.x to v6.x), Central Designer™ (v1.1 to v2.1), Architect™, IVRS, IRT, LNMT, DoD, Central Coding™, RDE

Clients: Quintiles, Parexel, NovoNordisk, GSK, Tibotech, Chiltern, Merck, Genmab, Oxagen, Novartis, Lilly Synopsis

The InForm system EDC and central designer is a data collection and trial management tool that harnesses the power of the Internet to provide access to clinical trial data and control of the clinical trial process. Trials are developed using Central Designer™ or Architect based on the InForm version. In addition to the trials design development, we integrate various solutions (standard and custom) such as IVRS, LNMT, IRT, IMPACT, OC, CTMS etc which basically used to integrate InForm product with other products to transfer data to and from the study to the third party systems. Main Responsibilities:

Access technical impact for upgrade/migrating InForm Study from 4.6, 5.x versions to 4.6.5, 5.5.x, 6.0.x, 6.1

Presenting project managers and customers about the technical challenges that come up in migration dry run of a study and explain the mitigation plan

Discuss technical and functional requirements with customers, conduct kick off meetings along with the requirements

Review Protocol and Interpret requirements (Multiple Site, Screening, enrollment and eCRF design)

Discuss technical queries and clarifications with customers

Design and develop data entry Rules - simple, medium and Complex Checks and lead trial development using Sprint model and waterfall model

Develop custom functions required for a study rules development

Performing unit and integrations of studies

Perform unit testing of custom functions by writing test cases in C# using NUnit

Integrating standard solutions such as IVRS, IRT, LNMT, OC and IMPACT to InForm studies designed using Central Designer

Configuring Cognos to study and develop and validate reports

Plan and Lead the Project Initiation meetings with Design consultants, Development and QA teams

Follow detailed specifications to design high quality eCRFs (electronic case report forms) for InForm™ using Central Designer or Architect

Update eCRF following QC (Quality Control) feedback, technical review and customer review of the InForm™ eCRF specifications

Update edit check specifications following QC feedback, technical review and customer review of the InForm™ edit check specifications

Expertise in managing a team of 14 from the technical delivery of project

Assign tasks to team members according to Project plan

Providing timely updates to the customer

Assist and provide estimates from Development and QA teams and give heads up to Project Manager on the impact analysis on Post go live changes of trials

Maintain working relationship with all internal and external parties

Co-ordinate with QA team for smooth running of project

Perform User Acceptance Testing (UAT) with customer, understand and respond appropriately to results of user acceptance testing and help resolve issues

Prepare Project Closure Report, TLR Documentation and capture lessons learned and submit to Management and Team

Updating Work Instructions to document any changes in process

Adhere to ICH-GCP and Oracle WI’s and SOP’s at all times Project: OutcomeLogix™ (version 2.5, 3.0)

Client: GSK (Japan), Takeda (Japan), Medtronic (US) Main Responsibilities:

Involved in development of Post Marketing studies using OutcomeLogix v2.5 and v3.0

Design Forms required for the study

Design and develop data entry Rules - simple, medium and Complex Checks and lead Study development

Assist Project Manager in the operational planning of the entity, managing the operational capabilities

Schedule tasks to resources according to Project plan

Assist and provide estimates from Development and QA teams and give heads up to Project Manager on the impact analysis on Post go live changes of trials

Maintain working relationship with all internal and external parties

Plan and Lead the Project Initiation meetings with Design consultants, Development and QA teams

Design and develop data entry Rules - Simple, Complex and Medium Checks and lead development.

Perform User Acceptance Testing (UAT) with customer

Understand and respond appropriately to results of user acceptance testing and help resolve issues

Prepare Project Closure Report, TLR Documentation and capture lessons learned and submit to Management and Team Senior Software Engineer

Virtusa June 2007 to Jan 2008

Project: InForm™ (version 4.5, 4.6, 5.0, 5.5)

Clients: Phase Forward (NovoNordisk)

Main Responsibilities:

Lead development of various InForm Studies using Central Designer and Architect

Involved in writing various types of rules based on protocol requirements

Involved in configuring IVRS and LNMT integration.

Involved in Unit and Integration testing of the studies and integrations configured. Software Engineer

Ritwik Software Technologies Dec 2003 to June 2007 Description: Developing Help Desk a web based application, it’s a product of Focal Technologies USA. In this Mainly two roles the Technician section and the Client section where the client can creates tickets (Ticket- A discussion startup for a problem), which will be solved by the technicians who has been assigned the particular ticket .There are different sub roles for each technician and client which will be assigned at the time of their registration, these roles can be changed by other technician or client who has role to edit the technician account or the client account. The clients will be charged for the problems posted by them, the charge will be depending on the technician assigned to solve that problem. This Project Includes a Windows service. All the Mailing Issues and creating Tickets on behalf of clients are handled by the service.

Role & Responsibilities on the above mentioned projects:

Involved in analysis, development, installing and troubleshooting

Generated Test Cases for Unit Test performed on the developed Code.

Developed the required procedures and methods to implement the business workflow and stages in document lifecycle. Environment: C#, ASP.NET, SQL Server 2000, Windows 2000 and IIS 5.1



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