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Business Analyst Resume

CA

SUMMARY

  • 7+ years of extensive experience in Business Analysis, Software Validation and business process re - engineering with proven ability to articulate business values.
  • Experience as a Business Data Analyst in Pharmaceutical, life Science domain.
  • 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).
  • Familiar with FDA Electronic submission standards and CDISC standards.
  • Extensive Knowledge of Systems Management, Design and Data Modeling.
  • 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.
  • Experience creating user stories and bug-tracking using JIRA & Visio;
  • Managed and traced requirements iRise
  • 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.
  • Work alongwith clients and support staff to determine the plans and strategies for different departments and projects
  • 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.
  • Excellent Training skills, facilitation, power point presentations, maintaining performance metrics, devising training documentation & communicating to users.
  • Strong understanding of information technology capabilities and dependencies, including platforms, content management, e-document strategies and process mapping.
  • 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.

TECHNICAL SKILLS

  • MS Visio, MS Project, Rational Rose, RequisitePro, ClearQuest
  • Windows XP/2000/Me/98/95/3.1/NT, OS X, SunOS, MS-DOS, Dream Weaver
  • Adobe Photoshop, Flash, Business Objects, iRise, XML, JIRA UML, HTML
  • C++, VB.NET,ASP.NET, Java, Access, Microsoft Word, Power Point
  • Excel, Outlook, PSP Studio, Word Perfect

PROFESSIONAL EXPERIENCE

Confidential, CA

Business Analyst

Responsibilities:

  • Involved in gathering business requirements from the end users and management.
  • Created high quality functional requirement specifications and supporting documents for business systems.
  • Assisted the Technical team with Formal Integration Testing of I-many Government Pricing. Created Testing Inventory report, Test Scripts and developed Formal Integration Test Cases. Also, assisted the technical team with parallel testing by being onsite with client as well as providing remote assistance.
  • Analysed the business and functional requirements of the application and developed detailed test plans, test cases in Test Director.
  • Used JIRA to document defects and Release tickets.
  • Worked with iRise Application Simulator to better communicate the design to the developers
  • Used Test Director and Mercury Quality Center for updating the status of all the Test Cases & Test Scripts that are executed during testing process.
  • Lead Business Intelligence reports development efforts by working closely with Microstrategy, Teradata, and ETL teams
  • Worked with data management and other groups to make sure that quality procedures are integrated into their work processes.
  • Designing and documenting Release Management Plan, documenting new JIRA requirements in line with our communication needs between two remote businesses.
  • Created use case scenarios and documented work flow and business process using Rational Rose
  • Reviewed the Functional Requirements of the COTS products and evaluated the integration of COTS with the existing system.
  • Responsible for establishing and maintaining positive business relationships with IT managers and clients, and ensuring that business objectives and priorities are aligned.
  • Created screen mockups using iRise Application Simulator to suggest the structure of a website and relationships between its pages
  • Work with the full SDLC, elicit, analyze and define requirements.
  • Performed Validation Testing on the application in accordance with 21 CFR Part 11.
  • Used DataStage Manager for importing metadata from repository, new job categories and creating new data elements.
  • Interpreted business objectives to support the implementation of technical software application.
  • Conducted meetings and understood the requirements of the sales and marketing team
  • Developed SAS programs for listing of tables for data review and presentation including adhoc reports, CRTs as per CDISC, patients listing mapping of safety database and safety tables.
  • Developed the Wire Frames, User Interfaces, AS-IS and TO-BE flows and the Use Cases to encapsulate the information with ease.
  • Requirement gathered from R&D, clinical trial data, scientist, research assosiate, regulatory affairs, sales and marketing, medical library.
  • Conducted Cost-Benefit Analysis of COTS products and comparison between COTS and In-house developed components.
  • PM/BA Liaison between two organizations to ensure appropriate communication plans, project plan, tool usage and release strategy were implemented and managed throughout the project SDLC. Accessing JIRA bug tracking application for best usage, deploy solution in line with Release Management Plan and train users on workflow, notifications and usage.
  • Performed extensive Requirement analysis and developed use cases and workflows.
  • Familiar with FDA Electronic submission standards and CDISC standards.
  • Working with clients to better understand their needs and present solutions using structured SDLC approach.
  • Involved in set up of testing methodologies and improvement of process model.
  • Design, development, implementation and roll-out of Microstrategy Business Intelligence applications
  • Used ClearCase for creating documents repository and sharing the documents across the team.
  • Created traceability matrix to ensure that the requirements are traced to the test cases.
  • Conducted UAT to confirm that all derivative products can be successfully processed through stages of the trade life cycle
  • Interacted with the developers to report and track bugs using Test Director.

Environment: Java, UML, Rational Rose, Requisite Pro, JIRA. Zachman Framework, ClearCase, ClearQuest, WinRunner 6.0, Load Runner 6.0, Rational Clear Case, Perl and Oracle 8.5 on Windows NT and Unix

Confidential, West Haven, CT

Sr. Business Analyst

Responsibilities:

  • Performed Requirement Gathering & Analysis by actively soliciting, analysing and negotiating customer requirements and prepared the requirements specification document for the application using MS Word.
  • Generated Reports on AE and SAE as a part of clinical data management process.
  • Managed internal R&D and client sponsored web based projects.
  • Reviewed the Functional Requirements of the COTS products and evaluated the integration of COTS with the existing system.
  • Identified opportunities for business process improvement through various meetings with business users and developers and initiated efforts to make improvements.
  • Gathered requirements and helped design the GUI using IRise
  • Familiar with FDA Electronic submission standards and CDISC standards.
  • Conduced User Interviews to determine the cause of the data Studied business requirements and conduced User Interviews to identify and document the data discrepancies and their sources as related to Government Contract Compliance (GCC), Government Disclosures, Government Pricing, Customers, Products, Product pricing.
  • Worked with iRise Application Simulator to create prototypes of the application
  • Implement the business intelligence plan that supports key long-term strategic needs and obtain all resources necessary for their execution.
  • The project/s involved various development, enhancement, production and R&D support activities connected to clinical microbiology.
  • Relate to payment obligations to large Group Purchasing Organizations and 340B Government Pricing.
  • Administration of Clinical R&D software including Oracle clinical, Clinapps PMD, Forecasting and sales and marketing software Spotfire and Cognos
  • Applied guidelines, standards and regulations such as HL7 CDA, CDISC, MedDRA, Code of Federal Regulations (CRFs) to clinical data modeling.
  • Created RUP activity diagrams and sequence diagrams to analyse the requirements and recommend solutions.
  • Government Disclosures, Government Pricing, Customers, Products, Product-Pricing.

    Using SQL queries, investigated data discrepancies between various source systems such as INTERACT, COACT, CARS/IS, Rebates- Chargeback and the Data Warehouse and the Price Point and Sales Data Marts.

  • Working with clients to better understand their needs and present solutions using structured SDLC approach.
  • Requirement gathered from R&D, clinical trial data, scientist, research assosiate, regulatory affairs, sales and marketing, medical library.
  • Used Data Mapping for the creation of conversion programs into CDISC (Clinical Data Interchange Standards Consortium )SDTM Standards from oracle clinical data.
  • Consolidated the analysis of multiple business lines after the COTS evaluation.
  • Developed business intelligence reports using Business Objects (BO) tool for the updated results to the stake holder
  • Designed, authored, reviewed and revised Clinical Data Management Plans and Drug Safety Technical Reports are FDA 21 CFR Part 11 compliant.
  • Prepare presentation slides in MS Project, which was extensively used in different JAD sessions and to track progress.
  • Designed and developed project document templates based on SDLC methodology.
  • Coordinated various kinds of User Acceptance Testing (UAT) including regression testing, system testing, integration testing, functional testing, alpha & beta testing.

Environment: Rational Suite (Rose, Requisite Pro), Rational Unified Process (RUP), JIRA, Windows NT/XP/2000, UML, UNIX, MS-Project, MS-Office Suite, Casewise, Corporate Modeller, WinRunner, Test Director.

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