SUMMARY:

• Broad knowledge within the field of project management, business analysis, business process design, application system analysis, object oriented analysis, system analysis in pharmaceutical and medical device sectors.
• Strong knowledge of software development life cycle (SDLC) including Waterfall, Agile Methodology, RUP having understanding of various phases like requirement, design, development and testing.
• Working as a Business Analyst of experience in Business Analysis, Requirements Management, Design, Development and testing in health care, health insurances related assignments and also as system analyst in pharmaceutical related assignments for drug compliance and testing with FDA and ERP domains.
• Facilitating JAD sessions with business user and development team to drive out detailed business requirements.
• Worked closely in clinical trials environment and accurate knowledge on Adverse Events (AE), Laboratory data, Demographic Data, CDISC SDTM and Regulatory Authorities.
• Analyzed business and technical requirements, thus creating the business use case (BUC) and application use case (AUC) documents.
• Experienced in creating Data Flow Diagrams, Use Cases, Class Diagram, Activity Diagrams, Sequence Diagram, and UML Modeling.
• Used Rational RequisitePro for overall requirements management and to build requirement traceability matrix.
• Utilized RUP to configure and develop processes, standards, and procedures and to perform system analysis and organizational review of existing QA processes.
• Extensive knowledge of compliance to FDA 21CFR Par t11, 50, 56, 58, 210, 211, 312, 314.80, 820.
• Implemented QA methodologies, practices and processes in all kinds of environments like Client - Server, UNIX, Web.
• Defining test cases, creating test scripts, analyzing bug, interacting with testing & developing teams in fixing errors.
• Gap analysis, understanding of cross-functional process, and understanding of business operation and process development methodologies.
• Used Rational Rose to carry out the business modeling, data modeling, and object modeling efforts to develop the business architecture for rapid and controlled application environment development.
• Analyzed business requirements from black box testing perspective, business process and system design.
• As a liaison between developers and management and between end users and stakeholders, was instrumental in resolving conflicts between the various teams.
• Business definition requirements, Requirements gathering time and Resource planning & scheduling, Business processes research, analysis, documentation, Use case, JAD sessions, GAP analysis.
• Experienced in creating Data Flow Diagrams, Use Cases, Class Diagram, Activity Diagrams, Sequence Diagram, and UML Modeling.
• Experience with various analysis methodologies, documentation processes, and project management tools includes: SDLC; Agile; Short-Cycle Iterations; Daily "Stand-Up" Meetings; Use Cases; UAT; MS-Project; SharePoint; eRoom; Visual Source Safe; etc.
• Expertise in preparing required documents for Computer System Validation (CSV) lifecycle, including Validation Master Plan (VMP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Validation Summary Report (VSR).
• Good working experience in cGXP (cGMP, cGCP, cGLP, cGDP) aspects.
• Expert in using different automated testing tools like QTP, Load runner and Quality Center.
• Performed Gap Analysis, understanding disparate Functional Processes, ability to identify and mitigate Risks and develop remediation plan
• Strong skills in back-end testing using SQL queries.
• Extensive Competency in writing, reviewing and executing Validation Protocols as per federal regulations.
• Excellent Communication, Interpersonal, Analytical skills and strong ability to work with minimal supervision as well as a part of team.

TECHNICAL SKILLS:

Content Modeling: MS- share Point, MS Project

Business Modeling: Rational Requisite Pro, MS Visio

Databases: MS Access, MySQL, MySQL Server, Oracle

Project Methodology: Rational Unified Process (RUP), Software Development Life Cycle (SDLC), Agile, Waterfall

Operating Systems: Mac OS, Window 7/Vista/XP/2000, Linux, Unix, MS DOS

Testing tools: Quality Center, Quick Test Professional (QTP)

Other Tools: MS Office Suite, MS Project

PROFESSIONAL EXPERIENCE:

Confidential, Irvine, CA

Sr. Business Analyst

Responsibilities:

• Wrote documentation for all aspects of the Computer Systems Validation Life Cycle using Requirement Matrix, in accordance with FDA regulations.
• Gathered requirements regarding the functionality of the new application and evaluation/analysis of the data.
• Maintained and updated the project related artifacts in SharePoint.
• Involved in user testing created documentation for Project managers in regards to views and publishing of MS projects.
• Responsible for detailing and documenting the key features of the application being envisioned.
• Conducted JAD sessions with the end-users to design essential core features of the system.
• Created clinical data-flows showcasing the main functional elements of the system including RDC (regulatory data capture), electronic data storage using CDMS (Clinical Data Management systems) and generation of Clinical Outputs (data analysis).
• Analyzed business data requirements and documented them using Visio.
• Prepared logical Process Models by analyzing the process flows of the various system components.
• Decomposed Business Requirements into Functional, Non-Functional, Reporting and Validation requirements.
• Coordinated research, analysis, development, and implementation of workflow-processes and technology solutions.
• Interviewed senior management, business owners, IT, and operations to create new process documents and materials.
• Gathered high level requirements through JAD sessions and converted them to low level through analysis.
• Created traceability matrices between the various requirement types - Business & Functional requirements and Functional Requirements.
• Worked closely with sponsors and clinical vendors to resolve operational issues to ensure protocol adherence and timely delivery of clinical trial data.
• Ensured system validation and change control documentation remained in a compliant state.
• Developed test protocols and summary reports for all upgrades/enhancements.
• Authored, implemented and maintained system procedures.
• Updated and modified project progress in MS project for the team.
• Conducted SOP and system reviews.
• As a liaison between developers and management and between end users and stakeholders, was instrumental in resolving conflicts between the various teams.

Environment: UML, Rational Suite, MS Visio, MS Project, MS Excel, MS Word, Service request.

Confidential, St Louis, MO

Business Systems Analyst

Responsibilities:

• Developed understanding of business requirements while working with business partners, subject matter experts (SME), enterprise architects, and application developers for integration of COTS and Custom applications.
• Worked with developers to engineer more complex business solutions in SharePoint.
• Collected requirements from Project owners regarding SharePoint Administration and planning including user permissions and site collection governance implementation.
• Assisted Project Manager in creating resources allocation in MS project for the team for the new enhancement projects.
• Created Business workflows, Flow charts, and Screen mock-ups for new UI (User Interface) using MS Visio.
• Gathered business requirements, analyzed work flows, defined the scope, and performed GAP analysis.
• Performed planning and developed detailed schedules for all the projects; use MS Project Server to update and manage the schedule on a day-to-day basis and used it for reporting to client and upper management.
• Created all the required project deliverables as per standards and procedures. Met with client groups to convert user requirements into business requirements and user and functional requirement specification.
• Facilitated collection of functional requirements from system users, and prepared business and technical requirement specification documents.
• Utilized RUP to configure and develop processes, standards, and procedures and to perform system analysis and organizational review of existing QA processes.

Environment: MS Excel, MS Visio, MS Project, SharePoint, UML, SQL Server 2008, SDLC/Agile, Quality Center, .

Confidential, Waukegan, IL

Business Systems Analyst

Responsibilities:

• Developed understanding of business requirements while working with business partners, subject matter experts (SME), enterprise architects, and application developers for integration of COTS and Custom applications
• 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.
• Responsible for documentation with an understanding of 21 CFR Part 11, FDA, CDISC, ODM standards and SDLC standards for documentation.
• Performed requirement validation and eCTDs for FDA and Documentum Management.
• Create Change Controls and managing change controls and create Validation Scripts.
• Execute Validation Scripts (IQ, OQ, PQ) for Computer Systems, BMS systems and calibration systems
• Served as liaison for various business units to gather requirements and resolve issues for the upgrade of existing ERP system.
• Gathered business requirements, analyzed work flows, defined the scope, and performed GAP analysis.
• Performed planning and developed detailed schedules for all the projects; use MS Project Server to update and manage the schedule on a day-to-day basis and used it for reporting to client and upper management.
• Created all the required project deliverables as per standards and procedures. Met with client groups to convert user requirements into business requirements and user and functional requirement specification.
• Facilitated collection of functional requirements from system users, and prepared business and technical requirement specification documents.
• Utilized RUP to configure and develop processes, standards, and procedures and to perform system analysis and organizational review of existing QA processes.

Environment: MS Excel, MS Visio, MS Project, SharePoint, R, SAS, SQL Server 2008, Quality Center, QTP, Trackwise.

Confidential, Rahway, NJ

Business Analyst

Responsibilities:

• Involved in Inception phase of SDLC process to gather requirements and document them.
• Involved in project planning and coordination using Microsoft project.
• Established traceability matrix using Rational Requisite Pro to trace completeness of requirements in different SDLC stages. Developed estimates, project plans (Microsoft project), material, BI reports.
• Documented the user requirements, prioritized them and converted them as system requirements that must be included while developing the software.
• Designed and documented detailed business requirements and functional requirements.
• Conducted JAD sessions between the business users, Vender Team, & Subject Matter Experts for data migration issues for supporting systems.
• Conducted JAD sessions with business unit owners and portfolio team to capture business requirements and system behavior.
• Applied Business Rules and met with the different pharmaceutical departments in order to understand and obtain necessary regulatory information to construct quality requirement documentation.
• Ensured flexibility to meet changing requirements and business needs.
• Wrote SQL queries to make sure data was in the appropriate format to ensure compliance with FDA regulations for electronic data and records.
• Assisted in scheduling end user .
• Acted as a liaison between developers and management and between end users and stakeholders, was instrumental in resolving conflicts between the various teams.
• Facilitated UAT along with project stakeholders, SME and project manager.

Environment: MS Excel, MS Visio, MS Project, JAVA, C++, VB.net, SDLC, Quality Center, QTP.

Confidential, Teaneck, NJ

Business System Analyst

Responsibilities:

• Developed understanding of business requirements while working with business partners, subject matter experts (SME), enterprise architects, and application developers for integration of COTS and custom application.
• Worked with cross-functional departments in the development and implementation of Unique Device Identification System (UDI) based on the recent FDA Product Barcode Regulation.
• Review and approve qualification/validation protocols and reports (design & operations).
• Providing Business and Functional Solutions to the Agile PLM implementation Workflow.
• Assist in implementation of Unique Device Identification (UDI) on label and updating the product label, User Guide, IFU and Insert package labels.
• Preparing SOP on labeling and checklist on labeling requirement of different countries.
• Create Change Controls and managing change controls and create Validation Scripts.
• Execute Validation Scripts (IQ, OQ, PQ) for Computer Systems, BMS systems and calibration systems.
• Served as liaison for various business units to gather requirements and resolve issues for the upgrade of existing ERP system.
• Gathered business requirements, analyzed work flows, defined the scope, and performed GAP analysis.
• Performed planning and developed detailed schedules for all the projects; use MS Project Server to update and manage the schedule on a day-to-day basis and used it for reporting to client and upper management.
• Created all the required project deliverables as per standards and procedures. Met with client groups to convert user requirements into business requirements and user and functional requirement specification.
• Facilitated collection of functional requirements from system users, and prepared business and technical requirement specification documents.
• Utilized RUP to configure and develop processes, standards, and procedures and to perform system analysis and organizational review of existing QA processes.

Environment: MS Excel, MS Visio, MS Project, SharePoint, UML, SQL Server 2008, SDLC/Agile, Quality Center, QTP.

Confidential

Business System Analyst

Responsibilities:

• Involved in Inception phase of SDLC process to gather requirements and document them.
• Documented the user requirements, prioritized them and converted them as system requirements that must be included while developing the software.
• Collected and documented policies, calculation methods, business processes as well as business rules.
• Responsible for identifying and documenting business rules for EDMS implementations.
• JAD sessions between the business users, Vender Team, & Subject Matter Experts.
• Managed the changes to such specifications; track the life of a requirement both forwards and backwards; Projects like IRMS and Publication Management part of Electronic Document Management System (EDMS) and documented the validation plan.
• Ensured that project/requirement(s) are properly tracked and documented as per six sigma and Project Manager's needs.
• Created client documentation, acceptance tests plan and user procedures. Served as a tester for Performed automated testing using Quick Test Professional to make sure data was properly migrated to the new version of AERS (Argus Safety).
• Conducted systems and user acceptance as per 21 CFR Part 11.
• Managed Argus and Electronic Document Management System (EDMS) for automating R&D and Regulatory document repositories for submissions to the FDA.
• Documented application features and operations in detail, including screen layouts, business rules, process diagrams, pseudo code and other documentation.
• Applied Business Rules and met with the different pharmaceutical departments in order to understand and obtain necessary regulatory information to construct quality requirement documentation.
• Acted as a liaison between developers and management and between end users and stakeholders, was instrumental in resolving conflicts between the various teams.
• Facilitated UAT along with project stakeholders, SME and project manager

Environment: MS Excel, MS Visio, MS Project, SharePoint, UML, SQL Server 2008.