SUMMARY

• 7+ years of extensive experience in Business Analysis, Software Validation and business process re - engineering with proven ability to articulate business values.
• Competent in Creating Unified Modeling Language (UML) diagrams such as Use Case Diagrams, Activity Diagrams, Class Diagrams and Sequence Diagrams.
• Strong Business Analysis Skills including In depth knowledge of Software Development Life Cycle (SDLC), having thorough understanding of various phases like Requirements, Analysis/Design, Development and Testing and Practical knowledge of Rational Unified Process (RUP).
• Excellent knowledge in Component-based Development (CBD) and Commercial Off-the-shelf (COTS).
• Knowledge in the Informatica/ ETL (Extract, Transform and Load) of data into a data ware house/date mart and Business Intelligence (BI) tools like Business Objects Modules (Reporter, Supervisor, Designer, and Web Intelligence).
• Expertise in Software Development Life Cycle (SDLC), Object Oriented Analysis and Design Methodology.
• Hard-core experience involving Business Process Re-Engineering, Software Re-Engineering using RUP methodology and ERP Systems Implementation and Continuous Improvement techniques.
• In depth knowledge in Life sciences. Experienced in life sciences projects like Pharmaceutical chemistry, Pharmaceutics.
• Strong knowledge on the Systems Development Life Cycle (SDLC), Rational Unified Process Methodology (RUP), RAD, SWOT, and CRM.
• Proven expertise in creating test plans, UML diagrams, flowcharts, screen mockups and systems requirements specifications.
• Strong knowledge of FDA QS 21 CFR 820, 211 for Pharmaceutical and Life Science Industries and cGMP, GCP, GLP, CAPA, GRP, EMR, EHR & QMS.
• Worked on e-submissions and having good knowledge of CDISC, Code of Federal Regulation (21 CFR Part 11), ICH, GCP guidelines.
• Functional experience with concentration on Use Case modeling using UML, Business Process Modeling, Data Modeling, Change Management, Technical Training, Software Development methodologies, QA testing, and Systems Testing of client server and web-based systems.
• Strong experience in conducting User Acceptance Testing (UAT) and documentation of Test Cases. Expertise in designing and developing Test Plans and Test Scripts.
• Experience in conducting Joint Application Development (JAD) sessions with end-users, expert team, development and QA team for project meetings, walkthroughs and customer interviews.

PROFESSIONAL EXPERIENCE

Confidential, MI

Business Analyst

Responsibilities:

• Provided FDA 21CFR Part 11 Documentation Remediation for corporate-wide Clinical TrialSystem
• Requirement gathered from R&D, clinical trial data, scientist, research associate, regulatory affairs, sales and marketing, medical library.
• Worked with the software architects / developers to ensure that the applications conform to customer requirements.
• Followed the UML based methods using Rational Rose to create Use Cases, Activity Diagrams/State Chart Diagrams, Sequence Diagrams, and Collaboration Diagrams.
• Participated Testing and Evaluation of projects at established integration points to assess progress and identify key functionality issues.
• Analyzed the data collected and process maps to determine the root causes and identify opportunities.
• Identified and documented Issues, Risks and Gaps and their descriptions and impact, and provided recommendations and alternatives. Analyzed the Gaps for Training purposes.
• Maintained Test Matrix with the test results obtained during testing phase Participated in UAT and worked with Mercury Quality Center for bug and defect tracking.
• Data migration involved taking the dump of individual table dumps and loads it in the new server because of the space constraints.
• Conducted JAD sessions to facilitate discussion between the different users to resolve issues and come to an agreement.
• Documented monthly status reports for enhancement and modification requests for the development team to assist them in efficient tracking and monitoring of open issues of the project

Confidential, Rocklin, CA

Sr. Business Analyst

Responsibilities:

• Gather requirements by conducting meetings and brainstorming sessions with end users and SME and document them using Requisite Pro - the documentation tool offered by Rational.
• Extensively involved in data modeling Advisor to the criminal justice agencies stakeholders on the best practices.
• Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data within the Oracle database
• Worked on receiving Encounter files from their PBM (Pharmacy Benefit Manager), verifying the data content by transactional analysis.
• Expertise in Claims, Subscriber/Member, Plan/Product, Claims, Provider, Commissions and Billing Modules of Facets
• Converted EDM business initiatives into multi-year data management plan for this leading maker of biomedical devices.
• Created the configuration document for custom setup for various user groups such as HR, marketing, R&D & sales, research analyst & investigators.
• Administration of Clinical R&D software including Oracle clinical, Clinapps PMD, Forecasting and sales and marketing software Spotfire and Cognos
• Maintained benchmark controls to policies, company standards and contracts, performed vendor sourcing, pricing and contract negotiation, performed procurement, ensured compliance with service/joint interest contracts.
• Gathered requirements and modeled the data warehouse and the underlying transactional database
• Applications tested were integrated to mainframe Vantage system, which included business applications for new sales, policies, quotes, and web based applications.
• Identified/documented data sources and transformation rules required populating and maintaining data warehouse content.
• Lead Business Intelligence reports development efforts by working closely with Micro strategy, Teradata, and ETL teams
• Directed the clinical trial data capture and worldwide data collection systems for various therapeutic areas.
• Designedand implementedaweb service to support the outsourcing of clinical trial disclosure.
• Extensively used Visual Basic to create macros in order to make data migration testing more useful and compared results from the legacy databases to the new CRM database.
• Created Data Stage jobs to extract, transform and load data into data warehouses from various sources like relational databases, application systems, temporary tables, flat files etc.
• Use Cases and other Process Flow Models were designed using Visio and Rational Rose, Managed the completely testing process using Mercury Interactive Test Management tool Quality Center.
• Performed UAT and exposure to User Certification Testing (UCT) and Operational Readiness Testing (ORT)

Confidential, PA

Business Analyst

Responsibilities:

• Worked with the account managers, managements, and report requestors to gather requirements, get report requests.
• Involved in testing the Pharmacy Claims adjudication and Billing processing is done through PBM (Health Trans) and Claims Accumulation and Adjudication is done through Diamond.
• Identified/documented data sources and transformation rules required to populate and maintain data warehouse content.
• Performed Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data
• Participated as a core team member of a Clinical Development initiative to create an architectural business end-to-end solution for clinical trials as a standard for all remote data capturing clinical trials.
• Worked with SQL queries using MS Access for data manipulations. Develop and maintain sales reporting using in MS Excel queries, SQL in Teradata, and MS Access.
• Created macros for preparing test cases in Excel for validating process of P&L tool, order management, Allocation Strategies and Modeling.
• Participated as a core team member of a Clinical Development initiative to create an architectural business end-to-end solution for clinical trials as a standard for all remote data capturing clinical trials.
• Experience of Data Migration from disparate data sources into normalized data to eliminate redundant information and organizing the tables to easily maintain the table structures.
• Planned and documented procedures for data processing and prepared data flow diagrams for the application.
• Understand the As Is system, develop the To Be system concept, and prepare the System Process Maps.
• Used different ad-hoc analysis, the Reports assist in defining strategy for each customer category. Informatica was used for ETL process and Business Objects 6.5.1 & XI R2 are used for Reporting duties.
• Provided data modeling support to each logical data model according specifications of Edmans responsible for the hardware, software, upgrades, and patching of SharePoint equipment.
• Followed the UML based methods using Microsoft Visio to create Use Cases Diagrams, Activity Diagrams, State Chart Diagrams, Sequence Diagrams and Collaboration Diagrams.
• Created presentations explaining the entire report development process, while drawing a comparison between the legacy & the new report.

Confidential, Glenview, IL

Business Analyst

Responsibilities:

• Used Requisite Pro for the Requirement Documents Preparation and Prepared Business Process Models that includes modeling of all the activities of the business from the conceptual to procedural level. Followed top down, leveled technique for building Business Process Models.
• Defined the current clinical and financial business processes reengineering and practices.
• Reviewed administrative and clinical practices and procedures: point of care, scheduling, registration, clinical documentation, patient care, and charge entry, medical coding and diagnostic testing procedures associated with multiple business units.
• Assisted with development of strategy for managing SharePoint permissions in conjunction with Active Directory and future implementation of Identity Lifecycle Management functionality
• Created Use Cases / Activity Diagrams / State Chart Diagrams, Sequence Diagrams, and Collaboration Diagrams thus defining the Data Process Model and Business Process Model.
• Involved in creating and testing Professional, Institutional and Pharmacy claims through API to Diamond.
• Used MS Visio for Process modeling, Process mapping and Business Process flow diagrams.
• Worked with Claims, enrollment, eligibility verification for members and providers, benefits setup, and backend payment cycle in facets.
• Captured Data flow diagrams and formatting of the data flowing through interfaces. Performed EDI duties such as FTP of files to and from our Clinical Trading Partners.
• Customize and extend the Oracle E-Business Suite using flexfields, Forms Personalization, Oracle 10g PL/SQL and SQL*Plus scripts
• Worked on Pharmacy Systems' Condor Rx-90, CS-90, and CS-90+ prescription management systems
• Interaction with underwriters to understand multiple data points. Prepared data flow diagrams using MS Visio for better clarity and to ensure documented process
• Evaluated the Rational comprehensive approach to software development, featuring seamless integration between tools, services and best practices, enables the organization to successfully deliver high quality software while deriving impressive business benefits for their customers.