SUMMARY:

• 8+ years of industry experience as a Business Analyst with solid understanding of Business Requirements Gathering, Business Process Flow, Business Process Modeling and Business Analysis.
• Expertise in implementing the agile, Rational Unified Process and Waterfall Methodologies throughout the Software Development Life Cycle of the project.
• 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.
• Implemented Unified Modeling Language (UML) methodologies to design Use Case Diagrams, Data Flow Diagrams, Activity Diagrams, Sequence Diagram and ER diagrams.
• Lead JAD session and requirements review meetings with all functional groups and participate in industry events.
• Experienced in writing Business Requirements Document (BRD), Functional Requirements Document (FRD), Request for Proposal (RFP), Statement of Work (SOW) and Standard Operating Procedures (SOP).
• Hands on experience in vendor management and experience in CRM 2 full cycle.
• Initiated and Involved in Organizational Change Management (OCM) during migration from the old system to the new system.
• Experienced in MS Visio for UML modeling, DSR (Daily Service Reporting), Backup Procedures, Daily Workflow Procedures, Data Center Support and Service flow.
• Experienced in preparing and executing validation activities for equipment and utilities such as biosafety cabinets, gases, laboratory systems, incubators, stability chambers, freezers and refrigerators for the start - up facility; actively involved in the implementation of the Labware Laboratory Information Management System (LIMS) Project for Pharmacia Biotechnology.
• Experience in validating Laboratory Information Management System (LIMS), Adverse Event Reporting System (AERS), and Chromatography Data System (CDS).
• Experienced in performing Gap Analysis for 21 CFR Part 11 and remediation and also in validating Laboratory Information Management System (LIMS).
• Thorough knowledge of GRC regulation and policies.
• Extensive experience in reviewing and analyzing functional requirement specifications (FRS) and system requirement specifications (SRS) and writing detailed Test Plans, Test Cases, and Test Scripts.
• Excellent experience in working with FDA regulated environment, cGxP (GCP/GLP/GMP) guidelines.
• Strong Working Knowledge of SDLC, GRC 21CFR Part 11, COTS and software FDA validation practices.
• Functional experience in Manual and Automated testing tools including planning, design and implementation of tests and test cases, integration, system and regression testing and test efforts documentation management.
• Extensive experience as a validation analyst involved in all phases of SDLC. Conversant with all aspects of computer systems validation from Requirements to System and User Acceptance Testing and change control.
• Experienced in application 21CFR part 11, cGxP and CSV guidelines.
• Strong experience writing Test Plans and Test cases using requirements, use cases and design documents.
• Expertise in manual and automated testing tools (Mercury and Rational Suite of Tools).
• Experienced in software Analysis, Requirements Management, Quality Assurance and maintain Traceability.

PROFESSIONAL EXPERIENCE:

Confidential, Farmingdale, NY

Sr. Business Analyst

Responsibilities

• Analyzed application requirements with UML modeling (MS Visio) and documented Dialogue application output management and FileNet Enterprise Content Management solutions
• Completed an extensive data mapping exercise to make the existing on boarding system FATCA compliant and also assisted with requirements to develop an AML/KYC risk model
• Actively involved in validating the requirements and applying the RUP framework throughout the SDLC
• Analyzed business and user needs, documenting requirements
• Involved in the computer system validation (CSV) lifecycle, which matches with FDA regulations particularly 21 CFR part 11 and validation requirements like reporting features, password regulatory rules, password aging and session time-out for the LIMS system.
• Involved in validation of Labware LIMS and Open Lab including editing and review of protocols and post execution review for IQ and OQ effort.
• Conducted operational testing of Labware LIMS software and involved in writing of Operational Qualification of various LIMS modules.
• Worked with internal team, CROs and clinical sites to ensure the tracking and timely conduction of clinical studies.
• Documented Business Rules, Process flow diagrams, Content Analysis, Performance requirements and user guides.
• Developed the system requirements and design of a Documentum application that automated the process of taking CTMS generated documents and storing them as PDF.
• Worked with CTMS to support day-to-day operations in areas such as conducting study feasibility, streamlining the workflow of the trial coordinators and investigators.
• Developed statistical programs to perform clinical data analysis, review and approve results by using R, SAS and JMP.
• Performed Requirement Analysis to understand user needs for data Toxicology/ Pharmacology n-tier system.
• Lead the analysis, design and automation of client/ server applications using Oracle and SQL.
• Worked in compliance with FDA regulations and cGxP guidelines in all the aspects of Computer Systems Validation.
• Conducted validation and configuration of LIMS module as per 21 CFR part 11 Compliance.
• Initiated and performed automated testing of AUT using Quick Test professional.
• Created transition requirement document to allow users to be familiar with new CTMS System.
• Performed validation of laboratory equipment like GC/MS, HPLC, Spectrophotometer and Autoclave in compliance with cGxP guidelines.
• Documented the Validation Master Plan in accordance with FDA regulations, particularly 21 CFR Part 11, GLP and GMP.
• Communicated pertinent LIMS Requirements to site/system owners and gained consensus with management, IT, QA and scientists of departmental requirements.
• Identified, document business processes for LIMS and captured As-Is and To-be workflow process diagrams to illustrate exchange data between existing CDS and future LIMS.
• Conducted User Acceptance Testing and documented the UAT summary reports.
• Performed front end and back end testing, GUI, functionality testing and regression testing on AERS using QTP.
• Maintained the requirements traceability matrix (RTM) and mapped the modified test cases as per the new requirements.
• Validated AERS to ensure 21 CFR Part 11, electronic records, electronic signatures and cGXP compliance testing.
• Ensured the tracking of incoming Case Report Forms (CRFs) prior to safety review and upon manual review.
• Participated in the design and review of protocols, documents, regulatory submissions and reports.
• Identified optimum combination of application solutions to meet the requirements of business functions (LIMS EDMS, CDS, Project Server).
• Coordinate testing efforts of external systems interacting with core Labware LIMS application
• Facilitated and documented the scientific content, its usage, business process standards and technical requirements.

Confidential - Natick, MA

Business Analyst

Responsibilities

• Created Validation plan for Laboratory Data system and Computer Systems (CDS, SDMS, ELN) interfaced with LIMS.
• Performed Requirement Gathering & Analysis by actively soliciting, analyzing and negotiating customer requirements and prepared the requirements specification document for the application using MS Word.
• Used ISI Toolbox Pharma Edition efficiently for FDA submissions.
• Developed business and system requirements, program functions, best practices (GMP, GLP), FDA validation, and 21 CFR Part 11 conditions in a highly regulated environment, for submission of regulatory documents pertaining to drug development.
• Performed 21 CFR Part 11 GAP Analysis, Risk Analysis, Developed Requirements, Traceability Matrix (RTM) to track requirements for the software application module. Validated Lab Ware LIMS to meet 21 CFR Part 11 FDA Regulations.
• Implement CTMS to centralize all trial-related information, and improve clinical data management by equipping staff, including biostatisticians and database administrators.
• Worked with project manager, SMEs and assisted with the implementation of the Labware LIMS.
• Worked on project life cycle and SDLC methodologies including RUP, RAD, Waterfall and Agile.
• Conducted project kick off meetings with team members to explain roles / responsibilities, relationships with other groups, deliverables, timelines, assignments and status reporting.
• Actively involved in creating and updating the templates for the different folders and eCRFs in each application based on phase IV trials from CTMS.
• Involved in Functional, Positive, Negative, and Regression testing of Workstation/Equipment automation with LIMS and Empower.
• Requirements Elicitation, Analysis, Communication, and Validation according to Six Sigma Standards.
• Integrate Data from wide range of sources including in-house clinical data management systems, labs and contract research organizations and perform data cleaning.
• Developed SAS programming for extracting data from flat files, Excel spreadsheets and external RDBMS (ORACLE) tables using LIBNAME and SQL PASSTHRU facility.
• The user reported that the Good Manufacturing Practice (GMP) checkbox is checked which is preventing from dynamic referencing - Remediation successful.
• Extensively worked with Case Report Forms (CRF) during database design and developed various macros to filter data for phase II and phase III of clinical trials.
• Authored installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) deliverables for Labware LIMS.
• Involved in validation of LabWare LIMS by developing, executing and documenting SOPs, Test Plans and Test Scripts.
• Responsible for validating various Labware LIMS features such as like Lab station, Instrument Manager, Folder Manager, Business Reports and Standards and Reagents Manager.
• Involved in preparing the compliance report featuring the existing status of the cGLP, cGMP sensitive computerized systems.
• Extracted data from disparate sources by SAS/ACCESS.
• Developed Traceability Matrix matching URS and UAT for various release efforts for Labware LIMS. Executed OQ and PQ test scripts and generated Test Summary Reports. Interacted with the Lead user and wrote PQ scripts and was responsible for User Acceptance Testing (UAT).
• Designed and developed Use Cases, Activity Diagrams, Sequence Diagrams, OOAD using UML and Business Process Modeling.
• Participated in the bug review meetings, updated requirement document as per business user feedback and changes in the functionality of the application.
• Clarified QA team issues and reviewed test plans and test scripts developed by QA team to make sure that all requirements will be covered in scripts and tested properly.
• Organized meetings to discuss outstanding issues with QA and developers.
• Wrote test scripts for User Acceptance Testing (UAT).

Confidential - Cambridge, MA

Business Analyst

Responsibilities

• Met with users and stakeholders to understand the problem domain, gathered customer requirements through surveys, interviews (group and one-on-one) along with JAD sessions.
• Created business use case, user requirement document (URS), functional (FRS) and technical documents for trading system.
• Applied Unified Modeling Language (UML) methodologies to design Use Case Diagrams, Activity Diagrams and Sequence Diagrams in Rational Rose.
• Established RUP (Rational Unified Process) methodology and provided assistance in developing Use cases and project plans.
• Created use-case scenarios and storyboards in MS Word and MS PowerPoint for better visualization of the application and managed them using Rational Requisite Pro.
• Designed the UI of the application, prototyping and wire framing in MS Visio for better illustration of the application.
• Requirements Elicitation, Analysis, Communication, and Validation according to Six Sigma Standards.
• Designed and developed Use Cases using UML and Business Process Modelling.
• Resolved issues and improve the process to ensure a stable and accurate solution.
• Used MS Visio for Process modeling and Business Process flow diagrams.
• Responsible for the regulatory management process for the services provided by the pharmacy.
• Developed Use Case diagrams, business flow diagrams, Activity/State diagrams and Sequence diagrams so that developers and other stakeholders can understand the business process.
• Performed cost-benefit analysis, generated reports for analyzing various investments and their profitability and also for analyzing various lost opportunities due to time delay in investing.
• Validated business rules and all artifacts with users, approval and sign off.
• Analyzed data, logical data modeling, created class diagrams and ER diagrams in Rose for designing databases.
• Worked with the team on security features: web, encryption, authentication and SSO possibilities
• Updated and modified progress and resources allocation in MS project for the team.
• Created test plans and scripts, facilitated user acceptance testing and tested strategies with developers and testing team.
• Performed manual front-end testing to check all functionalities of different modules.
• Helped in Deployment of Portal a venue for the on-line trading application a Collaboration Bundle Solution.
• Ensured that the application met user and management expectations.
• Suggested measures and recommendations to improve the application performance.
• Designed and created Excel sheets to provide market analysis charts.

Confidential - Edison, NJ

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
• Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data within the Oracle database
• Gathered requirements and modeled the data warehouse and the underlying transactional database
• Perform Gap Analysis of the processes to identify and validate requirements.
• Identified/documented data sources and transformation rules required populating and maintaining data warehouse content.
• Conducted Cost-Benefit Analysis of COTS products and comparison between COTS and In-house developed components.
• Prepared an ROI analysis report after evaluating the COTS product of the multiple business lines
• Completed the documentation of Claims Scenario’s for the source system
• Analyzed the existing claims process and specific business rule logic will be applied in the ACP model.
• Organize requirements into high level Use Cases and low-level Use Case Specifications and modeled them into UC, Activity and Sequence Diagrams using Rational Rose and MS Visio.
• Apply UML notations and methodology in developing models that accurately represent the business process and workflows and clearly communicate them to the stakeholders.
• Facilitate JAD sessions involving the management, development and user teams for clarifying requirements and facilitating better communication.
• Designed Functional Specification Documents for the reports.
• Coordinate and prioritized outstanding defects and enhancement/system requests based on business requirements, allowing sufficient time frame to ensure accuracy and consider deadlines
• Assure that all Artifacts are in compliance with corporate SDLC Policies and guidelines.
• Review the Test Plan developed by the testing team for testing the application.
• Assist the QA personnel in the creation of Test Cases using Rational Test Manager.
• Involved in performing version control and defect tracking activities using Rational ClearCase and Rational ClearQuest.

Confidential, Stamford, CT

Business Analyst

Responsibilities:

• Involved brainstorming sessions with executive sponsors, project champion and stakeholders to document problems with existing CTMS and potential solutions.
• Involved in design and development of Clinical Trial Management System (CTMS) integrated with EMR and customized to suit protocols following CDISC, GCP and other FDA standards.
• Member of assessment team to study the 21 CFR Part 11 requirements.
• Helped in Writing the Validation Assessment for the management to understand the importance of validation of core business functionality.
• Worked with project managers and assisted with the implementation of the LIMS software in compliance with the FDA 21 CFR Part 11 requirements, using GAMP guidelines
• Gathered the User Requirements from the Business Users and the Business Sponsor.
• Coordinated with the Lead Developer to set up and build the prototype of the application.
• Assisted Creating a Validation Plan based on the Project Scope, Testing Objectives and Testing Plan.
• With help of team wrote documentation for all aspects of the Computer Systems Validation Lifecycle, in accordance with FDA regulations, particularly Part 11, including: Validation Plan and Protocol, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification.
• Assisted Creating the Test Plan for Protocol Execution and conducted Tester Training for the Test Script Execution.
• Set up the Exception Report Database and coordinated with the Lead Developer to resolve the bugs that was found.
• Reviewed Vendor Audit and Vendor Compliance report for LIMS software
• Maintained the Requirements Traceability Matrix (RTM).
• Drafted new SOPs and trained all users on the systems, implications and impact of 21CFR Part 11 compliant data systems on day-to-day functions.
• Actively participated in project meetings and discussions.