Kalyani Miriyala

Ph: 1-412-***-****

E-Mail: ac4pgh@r.postjobfree.com

Professional Summary:

Around 9.5 years of experience in design, development and implementation of windows and web applications.

Experience in Health Care Clinical domain – Analysis, eCRF designing, developing, testing, deployment and support of clinical trials and third party integrations like IVRS/IWRS, IMPACT documentation, testing.

Expertise in Electronic Data Capture product [ INFORM (4.6/5/5.5/6.1) ], Designing tool [ Central Designer (1.2/1.3/1.4/2.0/2.1)] and User Management tool [UMT]

Thorough understanding of SDLC.

Worked with ASP.Net, C# .Net, ADO .Net, VB .Net and SQL scripting.

Ability to understand Functional Requirements and Design Specifications.

Experience in phases of SDLC including Development, Testing, Implementing solutions, Documentation and user training/support.

Worked on multiple Technical streams with the clients of ORACLE India Pvt Ltd.

Experience in maintaining and providing production support for product development.

Adept and experienced in problem solving and providing solutions.

Conducted Code Reviews and Audits to ensure the quality of code and deliverables.

Strong Review and testing skills.

Experience in handling Defect Tracking tools JIRA, Primus and DTS (Internal tools).

Provide guidance and mentoring to peer and junior-level Programmers.

Ensure smooth implementation of the application addressing all the technical, functional issues and effectively communicate with the CDC (Clinical Design Consultant) and the team for issue resolution.

Possess good communication, analytical, interpersonal and presentation skills.

Experience in utilizing agile Sprint methodology for trial development.

Ability to work well individually, while being flexible and adaptable to rapid change.

Worked with the different customers of Oracle India Pvt Ltd; few of them are Tibotec, Charles River, Covance, Celgene, Merck, Chiltern, Novo Nordisk, Novartis, Daiichi Sankyo, Cancer Research UK, Incyte, DSP, Morphosys, Ipsen, WCT, Life Cycle Pharma TACRO, George Roche, etc.

Academic Qualification:

M.C.A from Acharya Nagarjuna University.

B.C.A from Acharya Nagarjuna University.

Achievements:

Received Extra miler award for the first 6.1 Inform trial.

Achieved Inform Developer Level 1 Certification.

Professional Experience:

Worked as a Senior Application Consultant in Oracle India Pvt Ltd, Hyderabad, India from Apr 2015 to June 2017

Worked as a Senior Application Consultant in Oracle India Pvt Ltd, Hyderabad, India from Oct 2010 to Jan 2013.

Worked as a Senior Engineer in Phase Forward Software Services India Pvt Ltd., from May 2010 to Sep 2010.

Worked as a Senior Engineer in Virtusa India Pvt Ltd, Hyderabad, India from Jul 2007 to Apr 2010.

Worked as a Software Engineer in Brainstorm Technologies, Hyderabad, India from Mar 2005 to June 2007.

Technical Skills:

Programming Skills : C, C++, C# .Net, VB .Net, Visual Basic

IDE Tools : Microsoft Visual studio 2005/2008

.Net Technologies : .Net Framework (2.0/3.0/3.5), ASP . NET, ADO .Net

Oracle Clinical EDC Tools : InForm, Architect, Central Designer, UMT, SOC

Web Technologies : JavaScript, HTML, CSS, XML

Version Control Tools : VSS, Surround SCM, SharePoint

Databases : Oracle 8i//9i/10g, SQL Server 2000/2005/2008

Web Server : IIS 5.0, 6.0

Operating Systems : windows 7/vista/XP/2000/NT/98/95, UNIX

Project Details:

Project #1:

Title : Clinical Trial Builds, Integrations and Custom solutions.

Organization : Oracle India Private Ltd.

Environment : Oracle Health Sciences InForm, Oracle Health Sciences

Central Designer, Dot Net 2.0, Oracle client 10g

Role : Senior Application Consultant

Duration : From Apr 2015 to June 2017

Clients : ORION, Stryker Corporation, Novo Nordisk….

Business Problem:

Oracle Health Sciences is a leading provider of integrated data collection and data management solutions for clinical trials and drug safety. The InForm ITM (Integration Trial Management) platform provides comprehensive data entry, edit-checking and query management functionality for data capture and data cleaning. The product’s robust reporting and analysis capabilities provide real-time visibility and access to trial data. With timely and insightful views into trial data, sponsors can make more informed decisions, mitigating risks and improving overall trial conduct.

Responsibilities:

Managing the team and handled multiple projects individually with great responsibilities, effort, taking initiative and giving the best productivity.

Involved in Faststart and Fastforward process of implementation for the trial builds.

Involved in PF Import and RWR process of implementation as part of FF Releases.

Proven ability to manage multiple studies simultaneously, from inception to completion.

Review case report forms (CRFs) and ensures their design meets the protocol criteria and captures all data required to support a high quality database and the planned analysis.

Involved in designing eCRF as per the customer clinical protocol and prepare the Edit check specification.

Involved in Base customizations to the trial as per customer requirement.

Mentor the team to resolve critical issues in their work.

Coordinate with the team, CDC’s, PM and QA for smooth running of project

Approaches the problems with perseverance and from various angles.

Manages priority well and good at multitasking while keep the quality very high.

Involved in effort Estimations for initial trial builds, Change orders and TCC’s.

Involved in developing custom functions required for the trial build.

Involved in UAT meetings for findings and clarifications to the clients.

Mentor and train the new joiners on InForm, Central Designer and UMT tools.

Project #2:

Title : Clinical Trial Builds, Integrations and Custom solutions.

Organization : Phase Forward Software Services India Ltd (Acquired by ORACLE), Oracle India Private Ltd.

Environment : Oracle Health Sciences InForm, Oracle Health Sciences

Central Designer, Dot Net 2.0, Oracle client 10g

Role : Senior Application Consultant

Duration : From May 2010 to Jan 2013

Clients : Tibotec, Charles River, Merck, Chiltern, Morphosys,

Novartis, Genmab, Ipsen, George Roche, Novo Nordisk,

Cancer Research, Incyte, DSP, WCT etc.

Business Problem:

Oracle Health Sciences is a leading provider of integrated data collection and data management solutions for clinical trials and drug safety. The InForm ITM (Integration Trial Management) platform provides comprehensive data entry, edit-checking and query management functionality for data capture and data cleaning. The product’s robust reporting and analysis capabilities provide real-time visibility and access to trial data. With timely and insightful views into trial data, sponsors can make more informed decisions, mitigating risks and improving overall trial conduct.

Responsibilities:

Managing the team and handled multiple projects individually with great responsibilities, effort, taking initiative and giving the best productivity.

Involved in Faststart and Fastforward process of implementation for the trial builds.

Involved in PF Import and RWR process of implementation as part of FF Releases.

Proven ability to manage multiple studies simultaneously, from inception to completion.

Review case report forms (CRFs) and ensures their design meets the protocol criteria and captures all data required to support a high quality database and the planned analysis.

Involved in designing eCRF as per the customer clinical protocol.

Involved in Base customizations to the trial as per customer requirement.

Mentor the team to resolve critical issues in their work.

Coordinate with the team, CDC’s, PM and QA for smooth running of project

Approaches the problems with perseverance and from various angles.

Manages priority well and good at multitasking while keep the quality very high.

Involved in Form Tech Review, Edit Check Review, and development of the trials to release to UAT, LIVE and TRN environments.

Involved in effort Estimations for initial trial builds, Change orders and TCC’s.

Involved in developing custom functions required for the trial build.

Rule development; change the configuration settings in UMT as per customer requirements and generating Admin files from UMT.

Mentor and train the new joiners on InForm, Central Designer and UMT tools.

Project #3:

Title : Clinical Trial Builds and Integrations

Organization : Virtusa India Pvt Ltd.

Environment : Dot Net 2.0 (WinForms), Oracle 9i, Surround SCM.

Role : Senior Engineer

Duration : From Mar 2008 to Apr 2010

Client : Phase Forward Software Services India Pvt Ltd.

Business Problem:

Phase Forward is a leading provider of integrated data collection and data management solutions for clinical trials and drug safety. The Clinical Trial product offers a complete set of features for streamlining data entry and Lab loading, discrepancy management and resolution, Patient and site reporting, data exporting, coding and system administration. Clinical trial is a roles-based clinical database. Management system that allows users to access to the areas of functionality they are permitted to use.

Responsibilities:

Involved in analysis, planning, reviewing the work done related to trial builds.

Involved In development, unit testing, integration testing and code review of the rules.

Development of work and implementation instructions and release management.

Created files from UMT to upload users, rights and roles, sites and configuration settings information to the trial.

Involved in effort Estimations for initial trial builds, Change orders and TCC’s.

Mentor the team to resolve critical issues in their work.

Managing the team effectively by prioritizing the tasks.

Mentor and train the new joiners on InForm, Central Designer and UMT tools.

Involved in Form Tech Review, Edit Check Review, and development of the trials to release to UAT, LIVE and TRN environments.

Project #4:

Title : Merck Data Conversion

Organization : Virtusa India Pvt Ltd.

Environment : Dot Net 2.0 (WinForms), Oracle 9i, Surround SCM.

Role : Software Engineer

Duration : From Jan 2008 to Feb 2008

Client : Phase Forward Software Services India Pvt Ltd.

Business Problem:

MERCK is one of the clients to PHASE FORWARD. The project is to convert the data from legacy system, which is used by Merck earlier to InForm. It will be used to move clinical data for active trials to Inform. Conversion will be done for one trial at a time.

Responsibilities:

Worked on Patient Data Utility, which is used to create MedML, save MedML and validate MedML.

Interacted with the onsite people for requirements.

Sending the daily status to the reporting manager.

Project #5:

Title : International Professional Services- Integrations

Organization : Virtusa India Pvt Ltd.

Environment : Inform Architect, Dot Net 1.1, Oracle 9i

Role : Software Engineer

Duration : From Sep 2007 to Dec 2007

Client : Phase Forward Software Services India Ltd.

Business Problem:

PHASE FORWARD is a leading provider of integrated data collection and data management solutions for clinical trials and drug safety. Once trial development is done and trial is implemented in production, PHASE FORWARD integrates the trial with third party tools i.e. IVRS (Integrated Voice Recognition system), IMPACT, Lab Upload, safety are some of the Integrations done by PHASE FORWARD to automate certain elements.

Responsibilities:

Preparing configuration files for integration.

Preparing Implementation instructions for LIVE,UAT and Training.

Integration testing as per the test plan.

Prepared and executed unit test cases.

Project #6:

Title : Jewelry Gear Management System

Organization : Brainstorm Technologies

Environment : C#, ADO. Net, SQL Server 2000, Windows 2000.

Role : Software Engineer

Duration : Jan 2006 to June-2007

Client : Ali Gems, Hong-Kong

Business Problem:

Ali Gems is one of the largest wholesale Jewelry businesses in Hong-Kong. This project is aim to automate the process of jewelry making based On the Quotation Placed. The major business functions of jewelry business are Inventory Management, Purchase Management, Production Management, Order Entry Management and Accounting Management.

Responsibilities:

Member of development team, assisted in writing functionality as per the Specification provided by managers.

Involved in Designing and developing pages of Inventory Management module

Written stored procedures.

Used Currency converter to change the currency from local currency to required Currency type.

Prepared and executed unit test cases.

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