SUMMARY:

• Overall, 9+ years of extensive experience as a business analyst with strong experience in Pharmaceuticals with a solid understanding of Business Process Flows, and Business Analysis good documentation and process management skills.
• Experience in implementing the agile, Rational Unified Process and Waterfall Methodologies throughout the Software Development Life Cycle of the project.
• Experience in interacted with the Stakeholders, End Users to understand and gather stakeholder requirements and create the Business Requirements Document (BRD) and Functional Requirement Document (FRD) and communicating it to the entire team involved.
• Experience in implementing the Unified Modeling Language (UML) methodologies to design Use Case Diagrams, Data Flow Diagrams, Activity Diagrams, Sequence Diagram and ER diagrams.
• Experience with JAD sessions, use cases, activity diagrams, sequence diagrams, process flows, state diagrams, context diagrams, RTM's and system requirements.
• Experience in writing Business Requirements Document BRD, USE Case Specifications, Functional Specifications FS, Systems Design Specification, Workflow and diagramming skills for drawing UML diagrams such as Use Case diagrams, Activity diagrams, State Transition diagrams, Sequence diagrams, Class diagrams, Data Flow Diagrams DFD and Requirement Tractability Matrix.
• Experience in working on Clinical Trials to conduct global clinical trials and manage the large volumes of data generated and Assisted in Clinical Data Management and Clinical Trials Management.
• Experience in working with Clinical Trials, Clinical Data Management, FDA Regulations e.g., 21 CFR Part 11, cGXP, PDMA, GAMP and Health Insurance Portability and Accountability Act HIPAA.
• Experience in implementation with EDI, X12 transactions complying with HIPAA and HL7 standards and CMS Compliances/Regulations.
• Experience in working and Participation GLP, GMP and GCP suites and in 21 CFR Part 11 and GxP compliance assessments

PROFESSIONAL EXPERIENCE:

Confidential

Sr. Business Analyst

Responsibilities:

• Involved and Reviewed tools for LIMS decision support to be used by the site. Analysis of LIMS enhancements, troubleshooting issues, second tier application support and routine master data configuration as required within the lab Vantage
• LIMS application. Involved in configuring the laboratory information management systems, such as lab Vantage SQL LIMS, developing validation master plans and validating LIMS implementations Involved in Researched and documented the laboratory's existing business processes ensuring that a clear and accurate picture of the current state is captured prior to initiation of LIMS upgrading process Involved and participated in laboratory engagements and workgroup kick - off meetings to help bridge the gap between the lab experts and the
• LIMS Implementation Specialists Manage end user Network, LIS and Exchange accounts participated in testing, implementation and support of new application code and version upgrades and supported the clinical informatics group and end-users by monitoring the triage queue and resolving or dispersing client requests for assistance.
• Involved in reviewing the User Requirements to create Validation Plan and define the validation strategy, Roles and Responsibilities and all deliverables required for Validation of Lab Vantage LIMS. Involved and Analyzed Business Requirements and formed Use Cases, Use Case Diagrams, Navigation Flow, Business Flow Diagrams, Process Diagrams and Work Flow Diagrams for applications and created Activity Diagrams using MS Visio.
• Involved in conducting the walk-through sessions for Business Requirement Document (BRD) and Use Cases to discuss definite issues with stake holders, Architectures and Design & development teams and also did GAP Analysis. Involved in Partner with clients/peers/scientists/technical groups to perform quality reviews on business requirements in order to verify if the requirements accomplish the demands of the end users. Involved in creating the procedures for Sample manager
• LIMS system and work with Operations to implement. Involved in providing the expert support to informatics team in resolving variances issues through drill-down analysis. Involved and Used MS Access VBA and SQL to organize the data and produce the fast results. Involved and Created the User Stories, Acceptance Criteria to express requirements to the development team, and review completed stories using the JIRA Application. Involved and Created the procedures for Labware LIMs system and work with
• Operations to implement. Involved in providing the internal departments with monitoring and audit support of Medicare Part D claims to ensure
• CMS compliance. Involved in developing the user manuals, presentations and training manuals as per project specifications and timelines. Involved in Joint Requirements planning sessions (JRP) as a facilitator to gather requirements from the Business User and conducted many joint devel

Confidential

Sr. Business Analyst

Responsibilities:

• Involved and Worked on documenting Requirement Traceability Matrix (RTM) for traceability of requirements and responsible for end - to-end traceability of drugs from RECAP to RXCLAIM. Involved in analyzing the User Requirements Document, Business Requirement Document (BRD), Technical Requirement Specification and Functional Requirement Specification (FRS). Involved in preparing documentation for all aspects of the computer system validation life cycle, in accordance with FDA design control and regulations, particularly 21 CFR Part 11
• Involved and Contributed towards the initial analysis of the vast project definition document. Involved in defining and documenting the vision and scope of the project for each Wave. Involved with the QA team to conceptualize, determine and develop test approaches and methods for unit testing, integration and functional testing, load and usability testing according to the application complexity and test requirements. Involved and Worked with the clients on the verification process for the requirement phase documents. Involved in Coordinating with Business
• Process Re-engineering team to work on integration plans. Involved in following the UML based methods using Microsoft Visio to create: Use Cases Diagrams, Activity Diagrams, State Chart Diagrams, Sequence Diagrams and Collaboration Diagrams
• Involved in Research, analyses and writing hospital UB rules for claims, I/ OCE edit based on new regulation or policies and quarterly/annually database update. Involved in working on multiple project teams of technical professionals through all phases of the SDLC using technologies including Oracle, Erwin,
• Data Stage, Data Warehousing, WebSphere and Cognos. Involved in analyzing the "As is" and "To be" system documents to show the current and proposed functionalities of the system using MS VISIO. Involved in gathering requirements and modelled the data warehouse and the underlying transactional database. Worked on writing complex SQL queries using joins, sub queries and correlated sub queries to manipulate and validate data. Involved in Data Modelling of both Logical Design and Physical design of data warehouse and data marts in Star Schema and Snowflake Schema methodology. Involved in creation and execution of manual test cases in Quality Centre and automated Test Cases in QTP and analyzed the Test Results. Involved in understanding of SQL Database and data warehouse design principles (e.g., facts, dimensions). Involved and worked with various groups, including business owners,
• SMEs and marketing team, for requirements gathering in definition Stage. Involved in Facilitated JAD/JAR and brainstorming sessions to gather requirements. Involved in Analyzing, eliciting and documenting User and System requirements for each functional area. Involved in coordinate with Development and
• Business team to develop high level Business and Technical documents. I

Confidential

Business Analyst

Responsibilities:

• Involved in gathering the Business Requirements by interacting with Business users to author Business Requirements Document (BRD) using MS Word. Involved in analyzing the requirements and converted them to system requirements. Involved in facilitated JAD sessions to get more details about requirements. Involved in creating the Use Case Documents based on requirements and developed Activity Diagrams using MS Visio. Involved and Conducted Meetings periodically with SMEs at various phases of the
• Software Development Life Cycle (SDLC) to discuss open issues and resolve them. Involved in using MS Project to manage schedules, deadlines, and resources collaborate on the project. Involved in Coordinating with the System Analyst to author System Requirements based on the Business Requirement Documentation. Involved and Organized the Functional Design Documents (FDD) handoff meetings with the Business and technical team, explaining them the requirements, review the Functional Designs and getting a formal signoff. Involved in the validation strategy, created Validation Master Plan, validation approach and checklists such as 21 CFR Part 11, maintenance of electronic records etc. in order to show compliance with FDA requirements. Involved and Worked on the team for Labware LIMS enhancements and Environmental Master Data. Analyzed specifications, designed logic and wrote code for customization of the software, which included configuration in LIMS Basic, Crystal Reports and
• SQL. Responsible for assigning work to team members, providing weekly status to Project Manager. Involved in consulting with other developers to ensure compatibility with other modules and applications as well as with users and stakeholders to ensure that requirements were met. Involved in assessed
• Change Controls and implemented necessary changes in LIMS. Involved in Development and implementation of the Global Labware LIMS system for Confidential. Involved in working on the development of the Environmental Monitoring Program in LIMS. Analyze specifications, design logic and write code for customization of the software using LIMS Basic and SQL. Involved with the investigative site on issues concerning current clinical trials Involved in collaborating with the stakeholders to determine user requirements. Translate requirements into a global LIMS and lead the design of solution and its review with all stakeholders. Involved in the Configuring analytical analyses in LIMS/EMPOWER for the product release testing. Involved and reviewed the validation documents and troubleshoot LIMS issues. Involved in Validating the technical designs created by IT developers against functional specifications. Involved in
• Handling the change requests and updated documents related to change. Involved and Reviewed system - testing results with the project and technical teams. Involved and Tested application manually and verified actual

Confidential

Business Analyst

Responsibilities:

• Involved and understood the client's business requirements by interacting with stakeholders, Subject Matter Experts Involved in creating the Project Scope and Vision Document for the project. Facilitated JAD sessions to gather requirements and drafted minutes of the meeting with Action Items and Parking
• Lots. Involved in creating the Business Requirement Document from the JAD sessions. Involved and Participated in creating and documenting GAP analysis. Involved and took instructions from the Project Manager and Team leads and helped them in scheduling Project Involved in using MS Project to ensure on time delivery. Involved and created the Use case documents with the help of these documents created use case diagrams and identified the actors and the use cases. Involved in Guiding the new business analysts to create screen mockups for some requirements. Involved in using Visio drew Activity diagrams to describe the dynamic behavior of the system Assisted Functional lead and the functional team in creating FDD. Involved in under the guidance and instructions of test and development teams, assisted them to create TDD to some extent from FDD. Involved and
• Handled change request from the client by using the Change Request Form and followed the documented procedure. Involved in creating System Retirement Plan, Data Migration Verification, Data Management Report and Final Retirement Report for Electronic Systems such as Calibration Manager, LIMS, Foxboro, CAPA, Chromatography
• Data System, Manufacturing Data, Training Management and Series Batch Assignment. Involved in development documentation and deliverables dictated by the System Development Life Cycle (SDLC) and client Integration Life Cycle (IPLC). Involved in development and implementation of the Global Labware
• LIMS system for Confidential Involved in working on the development of the Environmental Monitoring Program in LIMS. Analyze specifications, design logic and write code for customization of the software using LIMS Basic and SQL. Involved and Conducted highly interactive meetings with project's stakeholders such as users, QA analysts, and project management team, identifying and resolving issues. Involved in walkthroughs and meetings with development team to discuss related issues. Involved and Jointly worked with Test lead to create Test Plan. Involved and worked together with test team to prepare Traceability Matrix. Involved and conducted the user Acceptance Testing (UAT) along with users and stakeholders and documented the results for same. Involved in the project for implementing Best Practices for Business Analysis in the organization and instrumental in the transition plan for Agile
• Development methodology using SCRUM. Involved and participated in creating training manual, conducted knowledge transfer sessions and Involved and Handled the change request and change management issues. Involved a

Confidential

Business Analyst

Responsibilities:

• GatheredBusiness Requirements by interacting with Business users to author Business Requirements Document (BRD) using MS Word. Analyzed the requirements and converted them to system requirements. Involved and Facilitated JAD sessions to get more details about requirements. Creating Use Case

  Documents based on requirements and Developed Activity Diagrams using MS Visio. Involved and conducted Meetings periodically with SMEs at various phases of the Software Development Life Cycle (SDLC) to discuss open issues and resolve them. Involved and used MS Project to manage schedules, deadlines, and resources collaborate on the project. Involved and coordinated with the System Analyst to author System Requirements based on the Business Requirement Documentation. Involved in organizing the Functional Design Documents (FDD) handoff meetings with the Business and technical team, explaining them the requirements, review the Functional Designs and getting a formal signoff. Involved and worked with the validation strategy, created Validation Master Plan, validation approach and checklists such as 21 CFR Part 11, maintenance of electronic records etc. in order to show compliance with

  FDA requirements. Involved in working on the team for Labware LIMS enhancements and Environmental Master Data. Analyzed specifications, designed logic and wrote code for customization of the software, which included configuration in LIMS Basic, Crystal Reports and SQL. Responsible for assigning work to team members, providing weekly status to Project Manager. Involved and consultation with other developers to ensure compatibility with other modules and applications as well as with users and stakeholders to ensure that requirements were met. Involved and assessed Change Controls and implemented necessary changes in LIMS. Involved in development and implementation of the Global Labware LIMS system for Confidential.

  Involved in working on the development of the Environmental Monitoring Program in LIMS. Analyze specifications, design logic and write code for customization of the software using LIMS Basic and SQL. Involved with the investigative site on issues concerning current clinical trials Involved in collaborating with stakeholders to determine user requirements. Translate requirements into a global LIMS and lead the design of solution and its review with all stakeholders

  . Involved in configuring the analytical analyses in LIMS/EMPOWER for the product release testing. Involved and reviewed the validation documents and troubleshoot LIMS issues. Involved and validated technical designs created by IT developers against functional specifications. Involved and Handled change requests and updated documents related to change and Reviewed system - testin