SUMMARY

• Analytical, goal oriented and result driven professional with 18 plus years of experience as a Senior Business Analyst/System, Project Quality Manager, Project Manager, Validation Specialist, Implementation Consultant in diverse domains such as pharmaceuticals, Healthcare, Clinical, Financial, Insurance, Market research, and Telecom systems industries.
• Over 10 years of experience in Pharmaceutical and healthcare experience performing Clinical Trial Management Study Implementation, Clinical Data Analysis and worked in EDC Clinical databases and products.
• Also worked as Lead ETL specialist, Validation Specialist, Project Manager, Clinical Study manager, Implementation Consultant and Business Relationship Manager
• Finance, banking on various projects in client server and web application projects including Portal implementation, workflow implementation, Analytical Data management tools development , ERP systems and search engine implementation.
• Excellent interpersonal communication skills and quick to adapt to new environments with strong problem solving and trouble shooting skills.
• Committed, passion for success and result, team player.

SKILLS

• Languages: ASP.NET, ASP, C , JavaScript, XML, C, HTML,, PL/SQL,
• Packages: MS- Project, MS Office Suite
• IDE: Visual Studio
• RDBMS and Tools: MS SQL Server, Oracle 8i/9i, MS Access, SQL Loader, TOAD, Erwin, Netezza
• Operating Systems: Windows 2003/XP/NT 4.0/2000/98/95, UNIX, Solaris, Linux
• Testing Tools: QTP, Quality center
• Documentation Tools: Sharepoint, Documentum
• Business Tools: Enterprise Architect, Rational Suite Rose, Requisite Pro , MS Visio
• EDC: RAVE, Central Coding, CRF Submit, and Amendment Manager, IWRS, IVRS, CTMS, LIMS, Cognos, SAS, Clintrial, .Net.

EXPERIENCE

Confidential

Senior Business System Analyst

• Work on huge projects like EIM Data Governance and Netezza migration. Also working as key interface between IT, Business and Pharmacy Domain in the key initiatives like Medication Therapy Management, Pharmacy Incentive and Smart Prior Authorization. Work with Third party Applications Implementations.
• Being the Senior Business Analyst to help the vendor to implement ITIL framework with the Tool
• Use SIPOC for requirements elicitation
• Work on identifying KPIs and key business process drivers.
• Work on Business Process flows.
• Extensive experience in gathering requirements and categorization of the requirement into Functional, Non-Functional and Business Rules.
• Experience in creating wire frames to communicate the ideas to SME's.
• Very good understanding of ETL process using Informatica.
• Working knowledge of Quality center and QTP.

Confidential

Senior Business Analyst

• Project: Image Tracking and Event Adjudication for CRF Cardio Vascular Research Foundation at NY
• Project Scope: This project is focused on Study, Site and User set up, Document Management, Image Analysis and management, Event Adjudication, Integration of data from other Systems and Reporting.
• Automate Image analysis and Event adjudication process. DICOM and non DICOM images are analyzed and events are adjudicated by CEC members. Image analysis is performed and analysis report is sent back to Sponsor.
• Participated in JAD sessions for gathering requirements, analysis, and design.
• Categorized the requirements into functional/Non-functional/Business rules
• Developed use cases/diagrams, conceptual model, behavior diagrams sequence, collaboration, state chart, Activity , using MS Visio.
• Developed use case narratives for all important use cases
• Responsible for the delivery of Business Requirements Documents BRD within project timelines.
• Worked closely with developers and business users, and participated in product design process and document reviews.
• Assisted in development of training material for the new system.
• Extensively involved in developing test specifications for the application.

Environment: Share point, .Net, TFS

Confidential

Senior Business Analyst

• End to End visibility project which is focused on analyzing the data flow across multiple data repository and generating the discrepancies in the data flowing from different source systems.
• Involved in identifying the existing business processes by interacting with subject matter experts.
• Assisted and Created project plans, scope documents, project timelines using MS project suite
• Responsible for creating Business Requirement Document, Functional Specifications Document and involved extensively in use case analysis using UML tool MS-Visio.
• Facilitated JAD Joint application development sessions on Business Requirement Document and Functional Specification Documents with Business Owners, SME's, Business Analysts, and Development Team.
• Facilitated demo workshops to Business Managers, Business Users and demonstrated the entire functionality of the product.
• Created and facilitated the walkthrough sessions on the screen mock-ups of the proposed product with Business Managers and Business Owners.
• Involved and supported the data base team in migrating data among different environments and also supported the team in deploying the updates to the production system.
• Facilitated End-To-End training to the Business Owners, Business Users and Business Managers during entire QA phase.
• Involved heavily in creating and running UAT test cases and test scripts.
• Involved and supported the QA team in fixing up the open defects by working with the current business processors and developers.
• Involved and supported QA team in writing system test cases by facilitating walkthrough sessions on Business Requirement Document and Functional Specification Documents.
• Responsible to absorb and document complex business concepts, processes, and requirements, and then accurately represent them with iterative refinement via interactive meetings with business and technology stakeholders.
• Work as a key interface between the business team, development team and Vendor team.
• Implemented and supported study build for Pharmaceutical companies
• Working on document management system like MIDAS, Documentum
• Working on Quality center system to use the test cases for Integration and Production Testing
• Prepare and present the details to Stake holder and Management.
• Worked on Projects with Inform Applications like CRF submit. Central Coder.

Environment: Windows XP/2000, Inform, Oracle, Clinical, CTS, MS Project, MS Visio, Sharepoint

Confidential

Senior Implementation Consultant

• Clinical Trail Implementation using RAVE
• Project Scope: Project scope is implementing the Clinical Trial Study. Study configuration, gathering the requirements for electronic Case Report Forms, build the data validation checks and implement the Study. Report generation, Data Integration of data from other Systems and also if migration is needed migrate data from one version to another version.
• Manager the entire Study build and team for multiple pharmaceutical clients
• Manage the project as a project/study manager in terms of scope and time.
• Worked on Clinical Business Process Management, trial analysis, design, development, testing, and implementation
• Implement the Complete Study from end to end in Rave.
• Plan, build, test and maintenance of clinical databases in Medidata Rave for assigned studies.
• Participate in reviewing the Case Report forms, Data validation plans.
• Worked on Standardizing as per CDASH and SDTM standards.
• Incorporates all external data sources e.g. lab, ECG, etc. with clinical database.
• Contact with sponsor to address database issues.
• Carry out Project Analysis Knowledge Certification Training Consulting. Lead the development of best practices and implementation processes related to study analysis and design and also in the Rave Amendment Manager.
• Acts as a lead in managing the other programmers. Mentors the other programmers and Study builders.
• Support Reporting Specialists during custom reports development regarding required functionality, assist SAS programmers during outputs configuration
• Support training group in preparation of course materials and delivery of courses both internally and externally e.g., clinical sites and investigator meetings as needed
• Support data integrations on studies with DIG on data transfer plan creation to ensure data integrations meet customer requirements
• Be as a center person to manage and coordinate the other groups like SAS programmers. Standard Groups, custom programmers, Medical coders.
• Conduct Training to the client about the best practices. Trained pharma, Biotech, CROs in RAVE.
• Work also on Production changes due to the Protocol amendment. Provide consulting to the client how to implement the protocol changes in existing Study.
• Efficient build knowledge in other Key products like Amendment Manager, Balance, Designer, TSDV, Safety Gateway, Coder.
• Worked on Trial Management in different Therapeutic Area Phase1, Phase2 and Phase 3 studies. Worked on Oncology study management including treatment data and Patient data.
• Worked on building global trial libraries for adaptive trials.
• Excellent experience in migration of trail data using EDC systems.
• Clinical Trial implementation using EDC applications like RAVE and Inform.
• Conducted EDC trainings RAVE for end users like Johnson and Johnson, PRA, AstraZeneca, Celgene, Baxter.
• Certified in RAVE

Environments: RAVE Medidata EDC Product

Confidential

Project Quality Manager, Validation Specialist, Informatica Lead

• Project Scope: Development Enterprise Data warehouse Infrastructure is a Central Data Repository that integrates Pre-Clinical Safety data, Clinical safety data, Clinical trial logistics data/trial metrics, modelling and simulation data. It provides a central and standardized repository to simplify exchange of data between applications and for the storage of data and metadata components that are used across multiple applications.
• Development Enterprise Data warehouse Infrastructure is a Central Data Repository that integrates Pre-Clinical Safety data, Clinical safety data, Clinical trial logistics data/trial metrics, modelling and simulation data. It provides a central and standardized repository to simplify exchange of data between applications and for the storage of data and metadata components that are used across multiple applications.
• Worked as Validation Specialist in Electronic Data Management Project.
• Wrote Requirement Specifications, Conducted training to Testing and validation team.
• Validated the EDC System by writing SOPs, Validation Protocols, Validation Reports and Validation test scripts.
• Worked as a Test Coordinator handling the entire team during validation and testing period.
• Involved in testing activities of Clinical Data Management activities like Data Entry, Data Validation and verification, Quality Control and error checking.
• Wrote User Requirement Specifications, Functional Requirement Specifications, Design Specifications, Wrote Validation Protocol, IQ/OQ/PQ Test plans. Participated in project design reviews.
• Worked on IMS
• Developed Unit test scripts, Integration test scripts, IQ, OQ and PQ test scripts and performed testing also.
• Performed 21 CFR Part 11 validations as per FDA regulations. Validated electronic records, signatures and audit trails.
• Creating functional / manual / system test procedures, Designing validation / verification test procedures and test plans, created and maintained the Traceability Matrix and Created DQ, OQ PQ Phase completion reports,
• Created Change Management Procedures, Software Development Plan
• Worked as a Test coordinator handling testing at various sites.
• Worked as a key coordinator between the Project Team and Business Users.
• Worked as a Project Quality Manager in Novartis managing all validation documents in the regulated 21 CFR part 11 systems. Participated in audits.
• Worked on Standardizing as per CDASH and SDTM standards.
• Be prompt and proactive in communication and in collaboration.
• Identify the Regulatory Risk.
• Writing SOPs which are business related and System related.

Environments: Informatica Power Center 5.1 on HP-UX, AIX 4.3.3, Power Connect for Mainframes, Powe Plug 5.0, Oracle 8.i, IMS, DB2, PL/SQL, Erwin 3.x, Cognos

Confidential

ETL Specialist

• Project Scope: The Financial Decision Support Environment FDSE is a dimensional data warehouse with a Cognos front-end web reporting facility that will empower analysts with the ability to utilize General Ledger data in the decision making process and tend to eliminate after-the-fact financial management.
• Created Complex mappings using Informatica Transformations
• Created process flow for Production environment.
• Involved in testing activities

Environment: Informatica Power Center 5.1 on HP-UX, AIX 4.3.3, Power Connect for Mainframes, Power Plug 5.0, Oracle 8.i, IMS, DB2, PL/SQL, Erwin 3.x

Confidential

Data Analyst

• Built Dimensional Models using ERWIN
• Extensively involved in Data Extraction, Data Mapping Data transfers
• Involved in creating Query-Intensive Dimensional Databases
• Coded and tested several Stored Procedures and Shell Scripts to automate the ETL

Environment: Informatica PowerCenter 1.7/5.0, PowerMart 4.7/5.0, Cognos 6.x, Impromptu, Power Play, Transformer, Oracle 8i, DB2, Excel Macros, MS OLAP, Visual Basic

Confidential

Lead Developer

• Business Analysis and Requirements Collection.
• Worked in development, testing phases of the project

Environment: Informatica PowerMart/ PowerCenter 5.0/1.7, Business Objects 5.0, Cognos, Pivot Tables, Oracle 8i, Sybase 11.9.2, MS OLAP, ERWIN 4.0/3.5.5, XML, ETL

Confidential

Lead Data Warehousing Specialist Consultant

• Business Analysis and Requirements Collection.
• Involved in building a Dimensional Model from a Relational Model.
• Created Dimensional Schema using Erwin 3.5.5.
• Involved in creating Query-Intensive Dimensional Databases.

Confidential

Programmer Analyst Consultant

• Creating database objects, tables, indexes, writing procedures, SQL scripts
• Created procedures to carry out the data Porting
• Created database triggers so as to check database integrity
• Developed Mappings using corresponding Source, Targets and Transformations

Confidential

Programmer Analyst

• Involved in analysis and design.
• Using Informatica Source Analyzer, Data warehousing designer, Mapping Designer Mapplet, and Transformations created mappings for the application.
• Developed Informatica mappings and tuned them for better performance.
• Designed the procedures for getting the data from all systems to Data Warehousing system. The data was standardized to store various Business Units in tables.

Confidential

Programmer Analyst

• Project Scope: AC Nielsen specializes in Market Research in the trade and household areas. The research data is compiled, validated, processed and converted to intelligent information with the help of many mainframe and client server based enterprise solutions.
• Involved in the design, development and testing of the system.
• Involved in Requirements Analysis, Reengineering and Functional Specifications.

Confidential

Lead Developer

Involved in the development and Testing activities.

Environment: Windows 3.11, Visual Basic 4.0, MS SQL Server 6.5, and InterSolve 6.0