SUMMARY

• Experience in 21 CFR Part 11 (Electronic Records and Electronic Signatures) remediation planning and implementation across all aspects of the business operations.
• Knowledge of cGxPs for Pharmaceutical, Biologics, Medical Device, and Quality Systems: 21 CFR Parts 210, 211, & 820.
• Experience with testing process that complies with FDA regulations, particularly 21 CFR, part 11,including Validation plan and Protocol, Installation Qualification (IQ), Operation Qualification (OQ),Performance Qualification (PQ) specifications.
• Hands on experience on EDIFECS Spec Builder, Transaction Management.
• Experience in Web Application Servers like Web Sphere, IIS, Web Logic and Apache and life ray web portal
• Applications like DME and NMP 2.0(Endeavor 2.0).
• Working Knowledge of Health, Life Insurance applications.
• Working knowledge of current techniques and approaches in machine learning and NLP (natural language processing).
• Extensive working experience on Medicaid and Medicare, Enrollments, Disenrollment’s, Plan changes, Reinstatements, Batch file processing Inbound and outbound CMS - Kaiser and Vice versa using Market Prominence Application customized for Kaiser owned by CPS.
• Highly motivated team player with excellent communication, presentation and interpersonal skills, always willing to work in challenging and cross-platform environment.
• Experience in entire SDLC and QA life Cycle.
• Formulating responses to questions in NLP (natural language processing) .
• Expertise in writing Test case, Test scripts and Test plan formulation.
• Designed and implemented Functional, Load and Stress test.
• Extensively used SQL queries to manipulate the data.
• Industrial experience includes healthcare (HIPPA and HL7), Insurance.
• Working knowledge on Conversion data Validation testing from Mainframes Core system to MP.
• Working knowledge on SOA Testing, Validating XML messages based on the mapping document using SOAP UI (Request and Response).
• Excellent knowledge in software engineering standards like CMM, Agile and RUP.
• Expertise in writing SQL & testing stored procedures and queries in Oracle.
• Experience in performing System, Functionality, User Acceptance, Integration, GUI, Regression testing.
• Excellent knowledge of Configuration Management and Version Control (MS Visual Source Safe 6.0, Rational Clear Case).
• Worker on clinical planning tools such as ClinVerse ClinTrial, ClinPay, and SaaSapplications for the enterprise. Customer facing information capture and incorporation of all application requirements.
• High interpersonal skills and ability to work individually and as a group member.
• Knowledge on HEALTH CARE REFORM plans that build on the current system by making changes in the tax code, adding benefits or broadening enrollment in existing programs such as Medicare, Medicaid or other plans. Other proposals, such as those that promote single-payer health care, would result in a full-scale change in the way Americans receive health care.
• Expert in AGILE/SCRUM Framework creating user-stories, epics, maintaining product backlogs, working in sprints & producing quality artifacts with process & quality improvement

TECHNICAL SKILLS

Operating Systems: UNIX, MS-DOS, OS/400, MS-Windows 95/98/NT/7, MVS.

Testing Tools: Rational Suite of Tools, Mercury Tools (6.0, 7.0, 8.0,9.0).

Applications Used: Market Prominence- Medicare,SOAP UI, NASCO Application, Mainframe terminal emulator Enterprise 7.1a, QNXT, Facets, ITS 14.0,14.5,16.0 Liferay web portal applications- DME and NMP 2.0(Endeavor),Edifecs Spec Builder, Transaction Management.

Bug Tracking tool: Quality Center 10.0, HP Quality Center ALM 12.01, MTM 11.0, TFS, QTEST.

Languages: C, C++, JAVA, HTML, DHTML, EJB, Servlets, JSP, SQL, PL-SQL, COBOL, JCL.

Development Tools: AS/400,VBScript, JavaScript, VB, Power Builder, FrontPage, XML, XML SPY, ASP, .NET.

Database: MS Access, Oracle 10G, DB2,XE Connect, Toad Data Point 3.2, Oracle Sql Developer 3.

Packages: MS-OFFICE, MS VISIO, MS Project (Documentation Packages)

Hardware Platforms: IBM, PC Compatibles.

PROFESSIONAL EXPERIENCE

Confidential

Sr. Business System Analyst

Responsibilities:

• Conducted meetings and JAD sessions with Product owners and Business users to collect business requirements.
• Conducted one-on-one interviews, brainstorming sessions, questionnaire sessions with account managers, business, and report requestors to capture requirements.
• Building Chatbot which helps simulate the conversion with the customer in naturallanguage through messaging application in website.
• Involved in complete SDLC i.e. Define, Analyze, Design, Produce, Implement, Verify and worked on reimbursement and customized solutions, medication therapy and safety through phamrcogenomics.
• Specifically captured security, access & privacy requirements adhering to standards.
• Conducted SIT & tracked the defects in legacy reports as per account managers and end users. Compared the results and tracked the differences in excel
• Conducted patient cohort browsing using search criteria’s such as demographics, ICD diagnosis, ICD & CPT coded procedures, lab test results etc
• Implementation, migration, custom development, and validation of Oracle-based Laboratory Information Management System (LIMS) using SQL* LIMS
• Involved in defining, documenting, and execution of the overall OQ process including the base LIMS and additional customized portions of LIMS.
• Using open source technologies which performs NaturalLanguage processing
• Analyzed trading partner specifications and created EDI mapping guidelines.
• Used SDTM to capture subject oriented data for EDC clinical trials.
• Wrote SQL queries using MS Access for data manipulations.
• Key resource to capture, analyze, review & document compliance & ad hoc requests requirements.
• Responsible for preparing Software Requirement Specifications (SRS), Functional Specification Document (FSD) and final Design Document as per SEI CMM standards.
• Prepared an analysis report based on the COTS (Commercial-Off-the-Shelf) evaluation. Consolidated the analysis of multiple business lines after the COTS evaluation.
• Refers to the task of NLP( Natural Language Processing) to determine whether a piece of text contains some subjective information .
• Prepared an ROI analysis report after evaluating the COTS product of the multiple business lines
• Created SAS programs that are used for data validation, statistical report generation and program validation and automated the Edit Check programs using Macros.
• Worked in AGILE & create storyboards, user-stories, wire frames while working in Sprints.
• Conducted Agile Retrospective meetings at the end of iterations while working in a SCRUM environment.
• Crafted User Stories using INVEST criteria and prioritized/grouped similar user stories together using Rally Agile Lifecycle Management Tool.
• Evaluate and planned to collect and report clinical performance using CRS tool.
• Data management and metadata reporting done using Informatica ETL tool.
• Assist the implementation and deployment of systems used for natural language input and processing.
• Owned the entire reporting process. Interacted with the ETL team, developer(s), management, and account holders to get the requirements, document them, design templates, and write specifications.
• Created and revised Business Requirement document (BRD) and Functional requirement Document (FRD) using the Scope and Interview with stakeholders.
• Developed eClinical solutions (EDC, IWRS, CTMS and eTMF systems) to single SaaS ClinPlus eClinical Platform
• Identified/documented data sources and transformation rules required to populate and maintain data warehouse content.
• Participated as a core team member of a Clinical Development initiative to create an architectural business end-to-end solution for EDC Clinical Trials as a standard for all remote data capturing clinical trials.
• Created and managed project templates, Use Case project templates, requirement types and trace-ability relationships in RequisitePro.
• Managed internal R&D and client sponsored web based projects. Referred to medical dictionary (MedDRA). Created and maintained custom medical drug and non-drug dictionaries
• Mapped process flow; assess as-is process through user interviews, data collection and analysis, design and evaluation of to-be process solutions. Developed data modeling, mapping and business process flow diagram.
• Involved in inspecting current validation documentation for LIMS & implement changes to streamline document management.
• Built multimodal conversational capabilities with NLP (natural Language Processing) where the robot is capable of not only deliver speech.
• Worked with the sponsors, stakeholders, Information Technology (internal and external (ClinPlus SaaS solution)) and QA teams to elicit requirements using various strategies e.g. - Interviews, questionnaires, requirement workshops, surveys, observations etc.
• Conducted GAP analysis of LIMS documentation for compliance to validation plan & requirements. Ensured conformance to ISO17025 & 21 CFR part 11 Electronic Records & Electronic Signatures to meet ISO accreditation.
• Created Test Scripts & Test Scenarios to check report content, layout, and parameters. .
• Developed and analyzed Test Scripts to check the functionalities of the application for 21 CFR part 11 compliant applications
• Reviewed Stored Procedures for reports and wrote test queries against the source system (SQL Server) to match the results with the actual report against the Data mart (Oracle).
• Involved in revalidating the system covering compliance gaps, existing functionality not originally tested or documented.
• Participated in risk sessions to address the risks and addressed project impacts to bring to light the possible workaround.
• Trained Implementation managers to work on the new application.
• Performed Feasibility Analysis and Risk Analysis on vendor/third party tools.
• Design and provide technical specifications for innovative features and enhancements for the company's SaaS platform and mobile applications.
• Machine Learning and NLP(Natural Language Processing concepts).
• Tested Claims Adjudication and Claims processing in AMISYS Advance.
• Scheduled and Ran Batch jobs in PreAdj and moved the information to AMISYS and validated the same.
• Created mockup templates for AMISYS Advance Screens (ME1600,CL0200,CL0100,CE0100, BE0100, ME0100, PR0100 etc) using MS VISIO as per the business needs.
• Worked on Membership, Benefits/pricing Management, Providers, Claims,Authorization and Medical management,customer service,finance, Billing and Account receivable and Enrollment applications in AMISYS Advance.
• Validated all the incoming/Outgoing data from EDI 837/835 interfaces in EDIFECS.
• Involved in Identify risks, dependencies, roles and responsibilities, tools, defect management and schedule.
• Involved in Functional, Regression and Integration testing and UAT testing.
• Developed Test Plans, Test Cases, Test Data, Traceability Matrix and Test Summary Reports and followed Agile/Scrum process.
• Involved in requirements gathering, business analysis and requirement analysis.
• Performed Test Case management, Defect Tracking and Execution status in QTEST.
• Tested Web Portal application and validating eligibility, claim information for different Line of Business.

Environment: - QTEST, Toad, Agile,AMISYS Advance 6.4.2, Edifecs, Oracle 10G, Ultra Edit, COTS, UNIX,SaaS, Microsoft Outlook Microsoft Sharepoint, MS Visio, NLP(Natural Language Processing), MS Office, Project Workbench and Windows XP.

Confidential

Sr. Business System Analyst

Responsibilities:

• Worked as a liaison between technology and the business clients to improve business processes and support critical business strategies.
• Documented the Use Cases and prepared the Use Case, Activity, Sequence diagrams and Logical views using MS Visio, MS Office and Rational Rose for a clear understanding of the requirements by the development team.
• Conducted client interviews and workshops to gain clear understanding of business processes to create functional and non-functional document for features releases
• Gathered requirements for new PBMS (Pharmacy Benefit Management System) and Medicare Part D claims processing, regulations etc. and produced BRD, functional specs and use case specifications document.
• Prepared documentation by conducting interviews with key business users to collect requirement on MAR (Medication Administration Record) for Suncoast Software to enable Caregiver to capture detail information about their medication administration.
• Include requirements and test scripts for Instruments Management that saved in the LIMS and they are available by responsibilities given that decrease the error and risk.
• Implemented NLP (Natural Language Processing) to analyze Customer Issues.
• Worked on MAR (Medication Administration Records), Conditions of Participation, Client Specific Pay Rate, and Zendesk Help Center. Impact included multi-million dollar revenue growth and increase in Complia services adoption.
• Worked in Scrum/Agile methodology and created/prioritized product backlog items using JIRA and created userstories.
• Worked on confluence to do templates, file versioning, document management for all projects in AGILE.
• Worked for software implementation, software upgrades and enhancements, POS products and Payment processing. SaaS, ERP API and Web Services projects.
• Gathered and documented government mandated requirement for Home Health Agencies (HHA) seeking Medicare or Medicaid certification required to meet the Conditions of Participation (CoP) which included compliance with OASIS (Outcome and Assessment Information Set).
• Using NLP(natural language processing) and other patented technology.
• Performed and facilitated sessions to build consensus on project priorities and requirements.
• Worked with off shore developers and quality assurance team to document risks, assumption, and defects
• Participated in the implementation and deployment meetings with Quality Assurance team to help create test plans and test scenarios and facilitate User Acceptance Testing (UAT) with the businessusers
• Gained in-depth knowledge of ContinuLink (Homecare Software) that includes plan of care, scheduling, assigning a caregivers, documentation, automated billing, payments, collections and payroll.
• Created internal training documents, user guides, videos and conducted Lunch and Learn sessions to educate on upcoming and future features and releases .
• Designed and developed NLP(Natural Language Processing) models for sentiment analysis.
• Data modeling using UML. Created Current process flows & future process flow using Rational Rose.
• Used SDTM to capture, document & analyze clinical variable data.
• Familiar with FDA guidelines (21CFR) and HIPAA (Health Insurance Portability and Accountability Act).
• Create and maintain Use Cases, visual models, including activity diagrams, logical Business process models, and sequence diagrams using UML.
• Documented all the aspects of Systems validation lifecycle in accordance with the FDA regulations, including Validation Plan and Protocol, Installation Qualification (IQ) Specifications, Operation Qualification (OQ) Specifications, Performance Qualification (PQ) Specification.
• Involved in preparing project plans and identifying major milestones for each stage as per the SDLC model (RUP Methodology).
• Used SoDA and created product documentation including online help, printed user manual, and training materials.
• Worked with 21 CFR rules and regulations to draft business rules and processes.
• Interacted with the client and the Technical Team for requirement gathering and translation of Business Requirements to Technical specifications.
• Formulated requirements for architectural business end-to-end solution for EDC Clinical Trials as a standard for all remote data capturing clinical trials.
• Captured, reviewed, analyzed & documented Siebel Clinical Trial Management System key requirements pertaining to improve investigator relationships, increase clinical research productivity.
• Interacted with business heads to finalize the Business Requirements for the application.
• Created and managed project templates, use case project templates, requirement types and traceability relationships in HP ALM.
• Worked extensively on Implementation, migration, custom development, and validation of Oracle-based Laboratory Information Management System (LIMS) using SQL* LIMS
• Involved in defining, documenting, and execution of the overall OQ process including the base LIMS and additional customized portions of LIMS.
• Worked into Healthcare claims process, EDI transactions, EMR (Electronic Medical Records), DSM (Direct Source Messaging) HIPAA (Health Insurance Portability Accountability Act), EOB, ANSI 837 UB92, 5010, HIX.
• Created technical and non-technical presentations to management and training workshop for end users.
• Interviewed area experts or SME’s asking detailed questions and carefully recorded the requirements in a format that can be reviewed and understood by both business people and technical people.
• Created and maintained Test plan from functional specification and Technical specifications.
• Extensive experience with XE Connect.
• Analyzed the impact of ICD 10 for Diagnosis/Procedure codes.
• Created Claims in Medical Claims and Hospital processing application
• Responsible for Business requirement Analysis, Use-Case analysis, Test Plan, Test Case and Test script development.
• Performed extensive Regression Testing for resolved defects.
• Validated HIPAA X12 EDI 5010 Transactions 837 I, 837 P, 835, 834, 270, 271, 276 and 277 through Edifecs Clearing house.
• Participated in testing various interfaces of Facets (Hospital claim/Medical claim/Diagnosis code/Procedure code/Benefit Matrix/ Modifiers).
• Responsible to check whether the interfaces and the extensions properly integrate with the Facets application.
• Retrieved production claims using Claim Retriever and used ICD-9 to ICD-10 convertor to replicate Production in Test environment.
• Extensive experience with Section 1104 (Administrative Simplification) of the Patient Protection and Affordable Care Act.
• Involved in testing the Member Enrollment, Eligibility Enquiry, Eligibility Response, Claim Status Enquiry, Claim Status Response and conversion of Financial Claims.
• Adjudicated Claims and Tested Migration Process.
• Integrated HIPAA functionality for standard transactions using Facets.
• Performed back-end testing by extensively using SQL Commands to verify the database integrity.
• Extensive experience to Develop/Use SQL queries to check the Data in the backend.
• Compared ICD9 to ICD10 claims for Pricing, Medical Definitions and Member Benefit Rules from Production to Test environment.
• Tested various interfaces (Inbound and Out bound) of Facets.
• Validated messages (General Inquiry, Informational and Claim Status) in Host and Home.

Environment: - Mainframes, DB2, Agile, Facets 5.2, XE Connect, CAQH CORE, Transaction Management 8.5.7 (Build 12576) Edifecs Spec Builder, Transaction Management, ITS 16.0, HP ALM 12.01, IBM Lotus Notes 8.5, UltraEdit Professional Text/HEX Editor Version 22.0, ICD-9, ICD-10,NLP( Natural Language Processing), MS Office, MS VISIO, SQL/PL/SQL, Oracle R12, TOAD, XML, SAP Field Glass, Windows 7.

Confidential, Houston, TX

Sr. Business Analyst

Responsibilities:

• Conducted meetings/interviews and JAD sessions with stakeholders, business users and traders to collect business requirements.
• Performed Feasibility Analysis and Risk Analysis on vendor/third party tools.
• Evaluate and planned to collect and report clinical performance using CRS tool.
• Data management and metadata reporting done using Informatica ETL tool
• Owned the entire reporting process. Interacted with the ETL team, developer(s), management, and account holders to get the requirements, document them, design templates, and write specifications.
• Created and revised Business Requirement document (BRD) and Functional requirement Document (FRD) using the Scope and Interview with stakeholders.
• Developed and analyzed Test Scripts to check the functionalities of the application for 21 CFR part 11 compliant applications.
• Documented the Use Cases and Activity diagram worked on COTS Integration and Application.
• Responsible for preparing Software Requirement Specifications (SRS), Functional Specification Document (FSD) and final Design Document as per SEI CMM standards.
• Conducted GAP analysis of LIMS documentation for compliance to validation plan & requirements. Ensured conformance to ISO17025 & 21 CFR part 11 Electronic Records & Electronic Signatures to meet ISO accreditation.
• Involved in revalidating the system covering compliance gaps, existing functionality not originally tested or documented.
• Conducted patient cohort browsing using search criteria’s such as demographics, ICD diagnosis, ICD & CPT coded procedures, lab test results etc
• Identified/documented data sources and transformation rules required to populate and maintain data warehouse content.
• Worked on Specialty Pharmacy, mail-order pharmacy, Pharmacy benefit manager as required.
• Participated as a core team member of a Clinical Development initiative to create an architectural business end-to-end solution for EDC Clinical Trials as a standard for all remote data capturing clinical trials.
• Gathered, documented, and performed user-acceptance testing (UAT) for brokerage internal product system reporting requirements.
• Prepared SDLC deliverables such as requirements documents, test plan, system integration test cases as appropriate for role.
• Analyzed various approach and techniques to elicit, analyze, document, and manage change to business and user requirements and interdependencies across work streams.
• Analyzed user problems, including manual business processes and identified, researched, investigated, defined and documented these processes.
• Participated in drafting surveys and interview questions for SMEs to gather requirements.
• Performed analysis and design projects using a systems development methodology.
• Writing test plans and executing System Test cases in Microsoft Test Manager these test cases / test scripts were developed after reviewing the business requirements document and technical specifications document.
• Automating Life Ray Web Member Portal application and Developed Visual C# Scripts for Off exchange Enrollment using QA Wizard automation Tool.
• Involved in End-to-End Integration Testing and worked closely with Development Team.
• Involved in Identify risks, dependencies, roles and responsibilities, tools, defect management and schedule.
• Involved in Functional, Regression and Integration testing and UAT testing.
• Involved in Life Ray Applications (Managed Care applications), Healthcare claims, HIPAA / EDI (834/837), Medical management portals and Claims Processing applications.
• Created workflows using MS VISIO.
• Developed Test Plans, Test Cases, Test Data, Traceability Matrix and Test Summary Reports and followed Agile/Scrum process.
• Involved in Web portal Application projects and validating the results as per Business requirements.
• Involved in requirements gathering, business analysis and requirement analysis.
• Coordinated with PM, BA’s, Developers and functional teams and coordinated meetings.
• Developed SQL queries/Unix Shell Scripts / XML Schemas/ Files and SOAP web services.

Environment: - Life Ray Web Portal Applications- Durable Medical Equipment (DME), Oracle R12, Oracle Sql Developer 3, MS Office, MS Visio, XML, TFS Web (Team Foundation Server), Microsoft Test Manager 11.0, Ultra Edit 16, Ultra Edit 21, Windows NT, MS-Word, MS-Excel, Microsoft Outlook 2007, QA Wizard, VB C# 4.0, HiSoftware Compliance Sheriff, HiSoftware Compliance Deputy, Deltek, Snagit 10,