SUMMARY
With more than 8 years of IT experience. Developed Interfaces integrating PI/XI with different versions of R\\3 4.6C, 4.7 and ECC 6.0. He has worked on implementation, Migration and Support Projects for SAP XI/PI (3.0, 7.0, and 7.1). He has experience on implementation of software applications in Manufacturing, Research and Life Science industries application using SAP and Oracle Clinical.

SAP PI/XI

• Experience in Integrating SAP and non SAP systems using SAP XI/PI.
• Experience in Seeburger Configuration using Seeburger Integration Suite.
• Experience in AS2, SFTP, File, JDBC, RFC, IDOC and SOAP configuration.
• Experience with SAP Solution Manager.
• Experience with EDI interfaces.
• Having Technical and Cross-Functional experience in various modules and applications of SAP R/3. Good understanding of business process procedures of SRM, FI/CO and SD modules.
• Involved in more than 2 full life cycle implementations.
• Excellent verbal and written communication skills along with strong inter personal skills.

Clinical Software

• Implementation, Design Validation, Project Coordination, Client Interaction, Troubleshooting, Debugging and testing of software based on a solid formal education and Specialize in analysis, design, development and
• Implementation of software applications and Life Science industries application using Oracle Clinical (4.0.3/4.5.3, 4.6) and SAS with Pharmaceutical and Biotech Research Organizations.
• Good communication skill with a strategic proven track record for interaction with client for various business and technical aspects.

TECHNICAL SKILLS:
Primary Skills: SAP XI/PI (3.0, 7.0 and 7.1), JAVA, Seeburger Business Integration Suite Adaptive SFTP Adapter, AS2, EDI 850 and 810, IDOC, Proxy, RFC Languages: JAVA, Oracle, PL/SQL, SQL, Base SAS, R programming
Databases: Oracle Clinical 4.X, Oracle, MS SQL Server 2008/2005/2000
Operating Systems: Windows, UNIX
UNIX shell scripting, HTML, XML
Development Tools: Oracle Remote Data Capture (RDC), TOAD, PL/SQL developer, Altova Spy,
Map Force, File Zilla, NWDS. Altova Spy, Map ForceClinical Data Mgm
Tools: Oracle Clinical 4.5.3, 4.6, AERS, TMS, FDA 21 CFR Part 11, SAS
9.1.3, BASE SAS, SAS/MACRO, SAS-SQL, SAS/STAT, SAS/GRAPH, and SAS - ODS, SAS/ACCESS

PROFESSIONAL EXPERIENCE

Confidential,Broomfield, Colorado Jan 2012 to Present
Project: SANDOZ SHAPE Implementation and Support
Role: PI Application Developer and Support

Sandoz Pharmaceuticals is based in Broomfield Colorado, a division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by patents. Sandoz has a portfolio of approximately 1,000 compounds and sells its products in 140 countries. Sandoz medicines are available to about 90% of the world\'s population and the company has approximately 25,000 associates. Sandoz's one of the recent acquisitions was Fougera Pharmaceuticals which is a global leader in dermatological ointments.

Responsibilities:

• Developed interfaces for Purchase order (PO) punch-outs for indirect sales request raised in Supplier Relationship Management(SAPSRM) system for vendors like Office Max, Sigma Aldrich, Motion, Dupli and VWR using cXML standards.
• Configured value mapping table for EDI 850 purchase order for customer like Sterling, McKesson, and Family Prix using Seeburger Business Integration Suite.
• Configure Message Splitter for EDI 810 Invoice and 850 purchase order for Sterling using Seeburger Business integration Suite.
• Developed interfaces for processing Payroll and Accruals Data with 3rd party company like ADP using adaptive SFTP adapter.
• Good understanding on concept of using network address translation(NAT) to securely route sensitive data in and out of an organization.
• Developed interface for Human Resource (HR Core) for sending sensitive data to SAP BI system using RFC module.
• Experience in end to end implantation and testing of an interface.
• Experience in understanding functionality of RFC code developed in ECC system.
• Involved in Phase 1 of Fougera project in which developed interface to send GP Extract data and Medicaid Payment data.
• Experience in using Bic mapper Designer to implement EDI interfaces like 850 and 810.
• Developed Design Documents, Transport Request Documents and checklist to move the interface to production.
• Good understanding of concepts like VPN, Firewall and Secure IP routing used in processing sensitive data in an organization.
• Experience in interacting with Business and Functional experts and clarifying them the architecture of the process implemented in an interface.
• Experience in integrating PI to PI system and sending to data to BI system.
• Experience with creating Service Request, Change Document and Incident tickets using SAP solution Manager.
• Supported business integration for Latin America, Canada and USA.
• Involved in MES (manufacturing Execution System)project for Brazil and USA, contributed in following interface developments
• Material Master
• Batch Master
• Bill of Material (BOM)
• Involved with IMS project for Brazil. This is a 3rd party application hosted outside the Sandoz network and attached to ORACLE database system. Developed following interfaces
• Sending Master Data to IMS system
• Sending Pay terms Condition to IMS system
• Sending Re-pass Conditions to IMS system
• Developed Design Documents (DD) and Review Document (RTR) for project stake holders.
• Maintained RICEF to organize each project time lines and deliverables.
• Experience working in an organization with (GMP) and FDA regulations
  

Challenges: Nature of the project was complex with more than 800 interfaces which had integrations with SAP FI/CO, SAP SD, SAP MM, and SAP BI landscapes. Implementing changes for Canada EDI 850 purchase order interface was a challenge. The same interface was used by 10 different customers and business logic was very complex meaning the interface was very sensitive to make any changes. There was a requirement in which business wanted to validate the purchase order using Material Number, Old Material Number from legacy SAP system and customer material number. To implement this change it was a challenge and was done in SAP PI system and ABAP function module used in the interface.

Environment: SAP PI 7.0.1.2, SAP ECC 6.0, Windows, Seeburger Integration Suite, Adaptive Adapter, BI 7.3,File, JDBC, AS2, SFTP,IDOC, Proxy, File Zilla.

Confidential,Chicago, Illinois April 2011 to Jan 2012
Project: Abbott Labs SAP Implementation
Role: PI Application support and Developer

Confidential, is based in Chicago, Illinois. They are the largest company in the nutritional products market and the second largest company in the worldwide market for diagnostic products. The company\'s product fall into three categories or production divisions: medical, pharmaceutical, and nutritional.

Responsibilities:

• Developing Interface related Technical Specs, Mapping Documents and Mapping Programs and then developed the mapping Programs, pipeline agreements and determinations and transported the interface to Test Environment.
• Co Ordinate with Client or Functional teams for Testing the operations of Interface and fine tuning if necessary upon successful completion of Testing moving the Interface to Production
• Supported production interfaces, involved in regular monitoring activities quickly resolving runtime issues in Production environment.
• Created variants in Production environment for ease of monitoring and created SQL Queries at Adapter Engine table to quickly report PENDING, HOLDING, FAILED, ERRORED message in Production environment based on timestamp
• Maintained daily error list and reviewed errors bi weekly and based on repetitive errors enhanced interface development and resolved long term errors,
• Documented maintenance check list for each plant and business case.
• Worked strongly to stabilize the production environment by recommending SAP standards on message size and load.

Environment: SAP PI 7.1, SAP ECC 4.6.

Confidential,Philadelphia USA Jan 2010- March 2011
Project : SAP Implementation
Role : SAP PI Developer

Project: Bridgestone Firestone is an international tire manufacturer with 45 production facilities throughout the Americas. The Nashville Tennessee-based company is the largest subsidiary of Bridgestone Corporation based in Tokyo, Japan. Tires are the largest part of Bridgestone, accounting for approximately 75 percent of annual revenues. In addition to tires, Bridgestone Americas is recognized internationally for producing a variety of quality products, including air springs, building materials, synthetic and natural rubber, and industrial fibers and textiles

Responsibilities:

• Responsible for creating technical design specifications based on business requirements.
• Translate business requirements into XI/PI technical solutions.
• Developed message mapping programs and used user defined functions as applicable.
• Configured Interface objects, mapping objects for Integration Scenario in Integration Repository, Data Types, Message types, Message Interfaces, Message mapping and Interface mappings
• Developed IDoc to File and IDoc to JDBC, File to JDBC, IDoc to JMS, JDBC to JDBC and File to File Scenarios.
• Gained good knowledge on SAP MM and SAP SD modules.
• Configured Alerts as part of Interface development at Alert Configuration.
• Transported developed objects from the development Server to Quality Server.

Environment: SAP Net weaver 7.0, SAP ECC6.0.

Confidential, Nov 2008 to Dec 2009
Project: GME (Global Model Enhancement)
Role : SAP XI/PI Developer

Project & Client Description:
Confidential, is all about the deployment of standard and integrated global business processes - Mfg, Supply Chain, Finance, Procurement, OTC, and Commercial. This is 7 year long implementation project. having advance Pfizer's business objectives and new Business Model Project provide timely and accurate enterprise-wide information to monitor business performance and Support merger synergies, but no explicit cost targets or business case Shared. Project scope is 50 markets , 66 manufacturing plants ,3 virtual plants, 3 Logistics Centers (LC), 40 Distribution Centers, SAP OTC, Finance, Supply Chain, Market DCs, Ariba for indirect.

Responsibilities:

• Full project cycle on XI (from analysis, design, development, documentation to support) by Coordination with different teams, onsite and offshore
• Involved in Quality Management, documenting technical specifications from business requirements.
• Development/Review of Involved and assisted the Functional team in Gathering the requirements from various vendors and clients. Assisted in translating the business requirements to functional specifications and technical specifications.
• Work as a PI developer space for the RICEF Team.
• Work with and help RICEF TL/LAS and Integration lead AS to make sure architectural direction, design, build and testing happens properly for PI based interfaces which technically provides a solid, high performance and flexible infrastructure for these interfaces at the same time meeting cost and time deadlines.
• This includes guidance on when to use and when not to use PI, providing architectural guidance, helping with complex designs, builds and testing.
• Working closely with client counterparts, functional teams, tech management and RICEF Teams of North America, China and India.

Environment: SAP Netweaver 7.0, SAP ECC6.0.

Confidential, April 2008- Oct 2008
Oracle clinical study developer/designer
Responsibilities

• Developed Study Design Documentation (SDS) using client protocol
• Built clinical database objects for multiple studies in Global Library in OCRDC 4.6 as per SDS which includes
• Discrete Value Groups (DVG's), Questions, Questions Groups.
• Created DCM's and DCI's as per SDS and generated Graphical Layouts in OCRDC 4.6.
• Designed new Case Report Form (CRF) in OCRDC 4.6 as per client CRF design Document.
• Created LAB, LAB UNITS and LAB conversions in PSILAB package to hold lab derived values.
• Worked on PSILABS to setup LAB questions holding lab-derived values.
• Created LAB DCM according to PSILAB documentation and generated character layout.
• Setup Procedure parameters like Variables and detail lines in derivation procedure module of PSILAB package to hold lab-derived values for the lab questions
• Setup up procedure and modify procedure using custom code as per client requirement
• Created Oracle clinical user accounts using windows environment and grant access using TOAD for Oracle 10.6
• Create user-using TOAD for oracle10.6 to give permission and add restrictions for users.
• Create or reset passwords for the user accounts using TOAD for Oracle 10.6 by connecting to the database server in windows environment.
• Worked on post production modification changes of the database
• Created Study Update Request Document (SUR) as per the changes requested by client.
• Worked on reset RXC_PD password required for both derivation and validations procedure generation using database server in windows environment
• Worked on Post production database modification changes of the study which includes the following:
• Moving Enhanced DCI BOOK to provisional status to make database changes.
• Inactivating the DCI at sites by removing the DCI from enhanced DCI book created in flexible study design.
• Making changes to conditional branching as per SUR
• Making changes at randomizations used at the DCI level to skip particular DCI as per the protocol requirement
• Testing the database in RDC ONSITE4.6 PROD TEST MODE and performing unit testing on the database before releasing the study for UAT to client.
• Reviewing and updating the UAT scripts required for testing post-production modification changes by client.
• Analyzing the regression issues with database modification and updating SUR for the study.

Environment:Oracle Clinic 4.6.2 Oracle RDC 4.6, PL/SQL, AERS, TOAD, MS-office, Windows, Windows Server 2003.

Confidential,NJ Oct 2007- March 2008
Clinical Programmer/Analyst
PRS Project: PROCEDURE REQUEST SYSTEM (PRS) is customized tracking system developed at BMS. It is used to request the any new, modify or copy both derivation and validation procedure at the time of database design and development of clinical study in oracle clinical 4.5x. This system involves different types of request such Global standard request, common procedure request, non standard/ study procedure request and PRS global library from DBD group.
Responsibilities

• Program to check invalid module IDs / CRF Exception numbers and missing PRS values in validated checks
• Program to check DCM module IDs with no validation requested in PRS
• Program and perform QC on validation and derivation procedures.
• Send findings to PDM for final review before validation procedures are developed according to requests using global standard guidelines at BMS.
• Writing programs to provide maximum reusability at CRF module level.
• Running procedures on multiple CRF modules (DCM subsets) per DCM and/or CRF Module ID not used in Procedure Name
• Running SQL checks on ORCLE objects through database development process checklist.
• Validation checks at OC study level definition level to copy standard from global library and non standard procedures from other study.
• Create test data to make sure validation procedure worked as expected from project database manager
• Release activation procedure for production after the test data gives the expected results

Project: OCRDC 4.6

• Built data entry screens and data structures for holding the data in Oracle databases using Oracle Clinical 4.6in and Windows environments on PCs.
• Made data validation programs to aid in data cleaning with Oracle PL/SQL in Oracle Clinical.
• Maintained the databases in OracleClinicalSQL PLUS, PL/SQL, stored packages, and stored procedures.
• Resolved discrepancies in RDC 4.6 and created internal annotation and FDA annotation according to CDICS and SDTM standards.
• Made programs to aid in getting queries to the sites about discrepant data.
• Imported data from ECRFs and lab data and made data validation programs for those as well and made specifications for building the ECRF entry screens.
• Gave access to users who needed to enter data or clean data or code data.
• Helped data managers with how to use the software and how to make their queries for discrepant data to sites for both OC and RDC 4.6.
• Developed training materials for OC 4.6 and RDC flexible studies.

Project: USER ACCEPTANCE TESTING (UAT): In this project the implementation of ORCALE 4.6 and Remote data capture 4.6 (RDC) was tested using HP quality center tool. This was a crucial project as it there was some of in house customization of the OC RDC 4.6 according BMS company standards so there has to be testing performed on each and every features of OC not just the new ones. Bugs were reported to ORACLE support and requested to release patches.

• Check implementations of OC 4.6 and customization according to company specification
• Execute the test scripts for both OC and RDC 4.6 in labs module of HP QC
• Reporting OC 4.6 bug to ORACLE support and get KT on how to resolve the issue
• Designing the Layouts in new OC 4.6 implementation and performing UAT to see if there are issue with the character and graphical layout
• Copying studies from other studies to check if there installation problem of the reference code lists
• Performing UAT on new extensive features of OC 4.6
• Testing the DCI access with using both inclusion and exclusion criteria with different user roles
• UAT using RDC 4.6 to make sure implementation of conditional branching and DCI access works at study sites
• Creating dummy studies using new flex study design and implementing interval rules, triggers to skip some of the questions that are not necessary at the site according Global Standard Exception approval.
• Resolving discrepancies on both OC 4.6 and RDC using UAT and also with some test data entry
• Linking error codes in HP QC tool while performing UAT ON OC RDC 4.6 implementations
• Approving of final test cases for QA team and SME review
• Reviewing Case Report Form (CRF) for both FDA and internal annotations according to company specifications and standards.
• Documenting new implementation and reviewing Database Design Manual of Operations
• Developing training materials for all the new features of OC RDC 4.6 implementations
• Conditional Branching, Flex Study Design, RDC Online Access
• DCI Access and USER ROLES

EMBARC UPDATION: In these projects the study modules were reviewed and updated to match the CDISC standards. In the SAS names and Variables names had to match to run a program that will replace the SAS data sets names to a customized tool developed at BMS. This is used by ETL team to get the SAS data sets for the analysis. Total of 150 domains were updated.
Environment: Oracle Clinical 4.5.3, 4.6, Oracle RDC, AERS, PL/SQL, SQL, SAS, HP QC 9.2, MS-Excel, UNIX, Windows, Windows Server 2003.

Confidential,PA April, 2005-Sep2007
Offshore project in Bangalore, India
Oracle Clinical developer
Responsibilities:

• Setting up Oracle Clinical Database for study protocols
• Created and generated Oracle Clinical Database Designs and Definitions based on protocol review.
• Created Questions, Question Groups (GLIB as well as study specific), DCMs, DCIs, DCI Books, Validation and Derivation Procedures.
• Involved in Edit check Specification review, Programming, Unit testing, user acceptance, and make them active.
• Identified edit check revision, modifying edits and review the discrepancies in production.
• Involved in Locking, Freezing and Unfreezing a study.
• Involved in Database IPR (Independent Peer Review) for new and modified database.
• Created default views, Test views and stable views.
• Involved in CRF/MSL review and annotation of CRF.
• Design, build and validate data entry screens (paper and/or EDC)
• Testing Data Entry Screens, Validation & Derivation procedures.
• Created setup and maintained questions, question groups, DVGs in the Global Library.
• Reviewing protocols and creating collection instruments used for capturing data in Oracle Clinical to support study analysis
• Used Oracle Clinical Web-based Internet Architecture with the ability to enter data from a variety of Case Report Forms and other data collection forms.
• Developed and maintained Oracle Clinical Validation and Derivation procedures (Edit checks with EDC).
• Data entry screens are user-defined to mimic the workflow used for studies.
• Using Global Library Management generated comprehensive CRF tracking, electronic data collection through RDC (remote data collection) and batch data loading from ASCII files.
• Used OC2 SAS to create SAS datasets.
• Generating HTML, PDF or RTF reports according to client specifications.
• Bio-statistical analysis with PROC ANOVA, Random effects in mixed Models mixed models.
• PROC SQL to perform queries, join tables.
• Generated tables, listings and graphs using SAS.
• Used data _null_ and PROC REPORT to generate outputs.
• Orienting new programmers.
• Delivering TLG's to clients and participated in off-site meetings. Point of contact for outside companies.
• Close work with Statisticians, Data managers. Univariate and Multivariate analysis using R and SAS
• Hyper variable analysis using R and SAS, Proc Means, Proc Frequency
• Merged data from several sources in to SAS analysis datasets mapping.
• Maintain data accuracy and track the results of the drug trail in accordance with SOP (Standard Operating Procedures), DMP and 21CFR Part 11.
• Acting as liaison with Biostatistics and user community and providing support for client area

Environment: Oracle Clinical 4.5.1, EDC, AERS, Oracle RDC, PL/SQL, SQL, SAS/Base, SAS/Graph, SAS/SQL, SAS/Macros, MS-Excel, UNIX, Windows, Windows Server 2003, SAS/STAT, Windows, Solaris, MS Visio.

EDUCATION
Maters of Science,
Bachelors of Engineering