SUMMARY

• More than 7+ years of experience as a IT Business Analyst in healthcare, Pharma and Medicaid domain.
• Created numerous SDLC artifacts such as Business Requirements Documents (BRD), Functional Requirements Documents (FRD), Requirements Traceability Matrix (RTM), Business Use Case documents, System Use Case documents, GAP analysis documents, etc. Strong experience in various SDLC methodologies like Waterfall, Agile.
• Worked closely with IT personnel and business partners to identify and maximize opportunities to improve products services and program business processes.
• Collaborating with clinical subject - matter experts and pharmaceutical companies to develop process flows and requirements to optimize end to end business processes that enhance patient experience and clinical trial efficiency.
• Gathered, documented existing system processes and data in order to perform gap analysis between client’s specifications of the desired system and the existing system.
• Facilitated JAD sessions between the stakeholders, Subject Matter Experts (SMEs) and the IT team.
• Coordinated with IT teams for business infrastructure and health plan operations.
• Formulated functional requirements and prepared process flows in Visio.
• Reviewed, analyzed and created detailed documentation of business systems and user needs, including workflow, program functions and steps required to develop or modify application programs.
• Assisted in various projects from start to finish through the SDLC process.
• Good knowledge of Safety reporting, Clinical Trial process, Data Management, Safety Data Processing and regulatory requirements (21 CFR- Part 11, FDA, DCGI etc.)
• Identified training requirements and documented user manuals for business users after the successful deployment of applications in the production environment.
• Knowledge of industry regulatory requirements (HIPPA) and medical coding like ICD9, ICD10 and working knowledge of GxP Compliance (GMP, GDP, and GCP), Audit Trail, and Electronic Signatures, IQ, OQ, PQ and21 CFR Part 11.
• Created numerous UML diagrams such as Use Case diagrams, Activity diagrams, Sequence diagrams, Business Process Flow diagrams and Entity Relationship Diagrams (ERD).
• Acted as project team member to combine a local and national claims processing system into one single platform.
• Experience in working independently and prioritizing tasks and workload efficiently.
• Experience in healthcare domain- Claims Processing, EDIs (837, 835, 834, 276, 999), ICD 9, ICD 10, Membership system, Provider Information system, Revenue Cycle Management (RCM).
• Coordinated and facilitated work sessions with Medicare Operations users to define project scope and requirements and managed project expectations.

PROFESSIONAL EXPERIENCE

Confidential, Bethesda, MD

Lead IT Business Analyst

Responsibilities:

• Gathers and analyzes the projects’ technical and non-technical requirements, document those needs as functional requirements and transfers the knowledge to the development team.
• Gather and understand customer / end-user requirements by conducting a Research, interviewing end-users, stakeholders.
• Work with development team in designing the application/functionality, database, reports, and processes to help in accomplishing stated business needs in most efficient way possible.
• Suggest improvements or enhancements to processes and systems to increase customer satisfaction or improve productivity.
• Present functional specifications to internal stakeholders for review/acceptance and compliance with requirements
• Coordinates meetings with various stakeholders discussing the impact of the system changes required
• Participate in impact analysis of changes to Systems identifying the risks, benefits and costs associated with the change.
• Evaluate, estimate the risk and Assist Managers with Risk assessment by working with a wide array of subject matter experts to fully understand the impact of a proposed change.
• Create and manage Process workflows, diagrams, wireframes and other project deliverables.
• Act as a liaison between the business and IT in translating complex business needs into application software.
• Demonstrates a high level of working knowledge with IS/IT methodologies and processes (i.e. Project Life Cycle, System Development Life Cycle and Change Management process)
• Work closely with developers and testers to ensure requirements and functional designs are translated accurately into working technical designs and that test plans and scripts serve customer needs.
• Involved in the SDLC (design, development, maintenance and support) of a Clinical Trial System using Oracle Clinical.
• Manages requirements traceability information and tracks requirements status throughout the project.
• Performed GxP assessments of new and existing systems, change control support/approval, project management/ execution, 21 CFR Part 11 assessments/remediation activities, developing validation plans.
• Conducted JAD sessions to allow different stakeholders to communicate their perspectives with each other, resolve any issues and come to an agreement quickly.
• Worked with Validation Manager in defining the boundaries of validation activities.
• Created and reviewed User Acceptance Testing (UAT) test cases for different modules of LIMS based on the User and Functional Requirement specifications (UFRS).
• Verified Process Mapping to outline initial validation plan and process control strategy.
• Conducted 21 CFR Part 11 assessments, reviewed/approved Application Management SOPs for Enterprise IT and Laboratory systems, and provided general consultation on GxP CSV system implementation and change controls.
• Performed backend testing by executing SQL commands using SQL*Plus.
• Reported Variances using Defect tracking tool and re-executed upon resolution using Test Director.
• Assisted in generating the Error Report Form and resolving the errors encountered during the testing effort and maintained the Error logs for the errors.
• Documented test execution report and prepared Requirement Traceability Matrix (RTM).
• Performed Gap Analysis of the system taking into account the User Requirements and System Requirements.
• Performed feasibility, adaptability study and risk analysis to identify the business-critical areas from user perspective.
• Adopted Agile/ Scrum through daily stand-ups, sprint retrospectives, group estimation techniques and customer sprint demos.
• Determined precise and accurate User Story acceptance criteria used by developers.
• Conducted Functional Requirement Specifications (FRS) and User Requirement Specifications (URS) reviews and walkthroughs with the designers, developers and stakeholders.
• Utilized reporting tools for project tracking, supporting the development team through every stage of the analysis.

Confidential - Lexington, MA

Business Analyst

Responsibilities:

• Participates with the Operations Manger to create a reporting platform for a worldwide pharma leader. Duties include requirements gathering (both business and technical), liaison to IT developers, report creation and design, project management, QA and technological innovation.
• Manages projects by analyzing the requests, maintaining timelines, determining requirements and feasibility and documenting output for all services.
• Converted Business Requirements to the Functional Specification to develop and architectural solution that the application meets the business requirements, resolve open issues, and change requests.
• Assisted in ongoing process improvement efforts to ensure Test Planning, Execution, and Reporting is effective, efficient, standardized, coordinated, and integrated.
• Review existing documents on SharePoint portal for clinical business processes related to operational support for Oracle Seibel CTMS
• Clinical trial management system the system maintains and manages the planning, performing and reporting functions, along with participant contact information.
• Document and maintain work products including Reports, WI, user guides, process flow maps, requirement attributes on SharePoint intranet portal
• Reviewed SOP's and Work Instructions and assisted in developing new documents. Have conducted the risk assessment and impact analysis for GxP projects.
• Developed Validation master plan and protocols for Installation Qualification (IQs), Operation Qualification (OQs), and Performance Qualification (PQs).
• Document system requirements and corresponding attributes related to clinical business processes
• Support data integration process for upcoming trials including review of data mapping specifications, establish timelines for testing, and production roll out of data feed files
• Participate in clinical admin and operational support including review, analysis and resolution of service/admin related issues logged on JIRA including
• Worked as a liaison with departments such as, Research, Clinical Trial, and Regulatory departments and often communicated with them and provided technical support throughout the product development
• Participate in documentation, periodic review of operational change requests related to system maintenance and enhancement
• Participate in UAT Testing, review of test results, re-testing activities for verification of implemented CRs
• Participate in project management activities to track deliverables and corresponding timelines
• Developed and coordinated test plans to verify the functionality of reports and QA checks to ensure reliability and accuracy.
• Reduced time-consuming reporting and QA processes by recoding and automating some of the exciting processes.
• Performed Web Page Mock-Ups using MS Visio and thus defining the Business Process Model and Data Process Model.

Environment: Agile/Scrum, SQL, UML, HP ALM, MS project, MS Word, MS Visio, MS excel, MS project.

Confidential

Business Analyst (IT)

Responsibilities:

• Confidential ’s Refreshment deals with 5 functional areas, such as Order Management, Route Sales, Product Purchasing, Customer Pricing, and, Accounts Receivable/Accounts Payable
• Monitored new Salesforce released features and functionality to provide recommendations for process
• Effectively gather requirements, document functional/non-functional specifications, use cases, business process flows for those 5 functional areas
• Planned and conducted requirements elicitation meetings with the business to collect functional and non-functional requirements relating to client's Salesforce technology enhancement and initiatives
• Prepared data mapping document for data integration between Banner (ERP)
• Record daily progress in VSTS and completed the stories that have been completed
• Work extensively with business on NetSuite ERP/CRM module including new
• As a part of the project, I was involved in drafting the To Be process flows for performance measurement and attribution to provide analysis, in turn, improving decision-making quality with full data transparency
• Worked with technical team in delivering the cloud based solutions involving web services, Apache Tomcat, iPad & iPhone Integration (SQLLite, Objective-C, REST API), Oracle E-business and Oracle CRM OnDemand
• Performed Gap Analysis of the "As-Is" and "To-Be" process within the organization to analyze and fill the existing gaps in the business processes.
• Wrote SQL queries to understand data relations and variances from other source systems.
• Mapping business process flows and creating flows in MS Visio
• Wrote and maintained detailed user stories in VSTS.
• Assisted in designing and implementing Salesforce technology functionalities.
• Utilized several system tests to detect bugs and worked with the ERP Development Support Analysts to incorporate feedback
• Identified Gaps with customization of Vendsys application and interfaces gaps with different databases
• Identified improvements in the TO- BE process to enhance the Vendsys application functionality
• Creating testable business requirement and in creating test plans for new systems implementation
• Good knowledge in route vending and micro market, e-orders, product and warehouse structures, AR/ AP
• Assisted with the BRD for the (POS) Point of Sale implementation project.
• Selected by management as the ERP Implementation Project Lead for Logistics, Quality, and Security.
• Acting as a liaison between the business and offshore programming/development teams
• Involved in the Support for a major effort to improve the Data Warehouse Management System (WMS) capabilities of Supply Chain.
• Creating Use Case documents and building Process Flow diagrams using MS Visio

Environment: Vendsys, MDM, Rally, Lightspeed, Hybris, MS Visio, Smartsheets, SQL, MS SharePoint

Confidential

Business Analyst

Responsibilities:

• Work closely with Business Owners and Stakeholders to outline Business Requirements.
• Work with Business analyst and IS teams to understand the flow of data.
• Created and Tested Validation and Derivation procedures using Oracle Clinical application and used custom code with PL/SQL and SQL, in order to maintain data accuracy
• Created and extracted Data Extract views in Oracle Clinical
• Gathered legacy business requirements by shadowing Customer Service Representatives (CSRs), Customer Relationship Representatives (CRRs), preparing questionnaires, to identify limitations in the current system and GAPS in the proposed system.
• Generated SAS datasets for the studies based on Oracle Clinical views
• Develop and maintain general-purpose SAS macros for data validation, extraction, manipulation, analysis and reporting;
• Modified existing SAS programs and created new programs using SAS Macros to improve ease and speed of modification as well as consistency of results.
• Developed prototyping, prepared the test data and checked for the feasibility of the system.
• Performed requirements gathering process in iterative approach using RUP methodology.
• Used Rational Rose for creating the Use Cases Diagrams, Activity Diagrams, Class Diagrams, and Sequence Diagrams etc.
• Reviewed documents/templates to create BRD and implemented the RUP process, identified Gap Analysis and the AS-IS and TO-BE model
• Created Mapping Documents, Report Mockups and modified existing report mockups and finalized for development
• Created Use cases, activity report, logical components to extract business process flows and workflows involved in the project using Rational Rose, UML and flow chart tools such as Microsoft Visio.
• Performed regression testing to ensure that the functionality matched with the Business requirements and fulfil HIPAA compliance for clinical trials.
• Created documents like the Business Glossary to facilitate the other teams in understanding client business in Requisite Pro.
• Formulated logical statements of business requirements researched and evaluated alternative solutions and recommend the most efficient solution for system design.
• Review requirements and understand technical recommendations and constraints, and develop comprehensive and accurate functional specifications; Data Mapping, and process flows.
• Work with Compliance and Regulatory operations to follow and monitor different IT process bound by CMS Regulations.
• Prepared Data Migration Plan and Data Migration Verification Report to migrate the data into test and production systems.