SUMMARY

• Over all 6+ years of professional experience as a Business Analyst in Pharmaceutical domain.
• Acted as a liaison between the business and the technical team in the areas of Software Design and Development Life Cycle and Web based technologies.
• Extensive Experience in Pharmaceutical, Insurance and Health Care Industries.
• Experience in developing FRD, BRD, SRS for multiple healthcare projects
• Experience with claims process and adjudication in the Medicare Part A, B, C and D, Medicaid and Private Insurance Sectors
• Expertise in EPIC, practice fusion, Medical software application EMR
• Well versed with Clinical quality standards for pay for performance based on HEDIS developed by NCQA
• Knowledge of implementation of a replacement MMIS, CHIP, MITA system and regulatory system
• Created Use Cases, Activity Diagrams and Unified Modeling Language UML to provide better view of the project to the stakeholders.
• Created business rules, business vision document, business glossary and implementation up to functional and technical specifications.
• Knowledge of compliance to FDA 21CFR Part11, 50, 56, 58, 210, 211, 312, 314.80, 820.
• Expertise in database design and development, Database audits along with working on HEDIS and Star - Reporting processes.
• Immense experience with using report builder, Discover (Ad Hoc) and Workspace Analysis.
• Experienced in testing different healthcare ERP solutions such as FACETS, Med Plus, EPIC and other claim processing solutions
• Experienced in Business and System Analysis, process improvement, project management.
• Created and managed JIRA templates and complex JIRA workflows including project workflows, screen schemes, permission scheme and notification schemes.
• Assisted team in the adaption to the SAFe Agile methodology including coaching and participating in Scrum Stand Up.
• Experience in conducting Joint Application Development JAD and Joint Application Requirements JAR sessions with end users, SMEs, and stakeholders.
• Strong Healthcare Domain knowledge with implementation experience in EDI, X12 transactions complying with HIPAA and HL7 standards and CMS Compliances/Regulations.

TECHNICAL SKILLS

Methodologies: Waterfall, RUP, Agile Scrum.

Tool: MS Visio, MS Project, Rational requisite pro, Rational Rose

Language: UML, SQL.

Databases: MySQL, SQL Server, DB2 and ORACLE.

Web Technologies: HTML, XML, MS SharePoint, Health Care/ Pharmaceutical

Domain Knowledge: MMIS, EPIC, EDI X12, HIPAA, HL7 compliant standards, ICD 9- 10, FACETS system, Medicare and Medicaid, Pharmaceutical research and development, PDMA, FDA, Evidence based practice.

Packages: MS Office Suite

PROFESSIONAL EXPERIENCE

Confidential, Indianapolis, IN

Sr. Business System Analyst

Responsibilities:

• Conducted user interviews, gathered requirements, and analyzed the requirements in Clinical research and pre-clinical development phases.
• Conducted JAD sessions with business unit owners, senior research management, and portfolio team to capture business requirements and system behavior.
• Documented test cases during requirements gathering, analysis and design phases.
• Maintained a proactive stance with business relationship(s) to ensure the business needs are always met within GxP Quality guidelines
• Worked on the Business requirement documents, User requirement specifications and functional requirement specifications documents.
• Used tools such as MS-Visio, Excel to define business use cases, activity diagrams, and sequence and state diagrams.
• Participated in full project life cycle, including gathering user requirements, screen and report design, in addition to implementation and roll out.
• Involved with implementation of laboratory and pre-clinical sample management softwares such as Waters NUGENESIS and BioBook to increase efficiency and reduce costs.
• Worked on Mercury tool such as Test Director to ensure that the test scripts are documented, reported and tracked in the Test Director.
• Migrated reports created using Crystal Reports version 9.0 to XI.
• Created SQL queries and views and used those objects to develop reports
• Assisted in Clinical Data Management and Clinical Trials Management.
• Assisted with user testing of systems (UAT), developing and maintaining quality procedures, and ensuring that appropriate documentation is in place
• Created client documentation, acceptance tests plan and user procedures. Served as a tester for systems and user acceptance as per 21 CFR Part 11.
• Facilitated meetings between Tier-3 development and Business owners. Developed Requirements and UAT test scripts for MARS.
• Involved in the preparation and execution of Test Plans, Test Cases, writing Test Scripts using Test Director.
• Analyzed and optimized the existing business processes using the conceptual modeling methods and documented the business process through DFD Data Flow Diagram narratives.
• Worked closely with ETL and BI teams during project implementation and actively suggest ways and means to share and optimize work.

Confidential, New York

Business System Analyst

Responsibilities:

• Involved in preparing Master Validation Plan for SAP R/3 system implementation.
• Prepared Validation Plan for every project implementation and involved in full cycle validation throughout all phases in SDLC.
• Developed Validation/SDLC Deliverables including User Requirements and System Requirements Specification documents (URS & SRS).
• Worked with SAP functional team to validate the transactions and modules to be complaint with 21 CFR Part 11 and GMP regulations.
• Experienced in testing Lab vantage LIMS system, which is an Laboratory Information Management System involving functional and user-acceptance testing.
• Involved in development of Master Test Plans and Test Scripts in OQ and PQ/UAT.
• Involved in Pre-execution review of OQ and PQ/UAT scripts and incorporated negative test steps to challenge the system. Also involved in Post review to verify the compliancy and documentation of scripts according to GDP regulations.
• Conducted Gap Analysis to demonstrate that LIMS System remains in a validated state in its life cycle.
• Prepared Traceability Matrix to keep track of relationship between all requirements and test scripts.
• Prepared Qualification Reports to qualify Barcode printers in manufacturing process.
• Validated a web-based application in accordance with GMP regulations, which is used in manufacturing processes.
• Prepared Test Summary Reports and Validation Summary Report to summarize all the activities performed during system validation.
• Monitored client expectations through client involvement and communication throughout the lifecycle of the project; educate clients and stakeholders on the benefits and risks associated with the project.
• Evaluated the Rational comprehensive approach to software development, featuring seamless integration between tools, services and best practices, enables the organization to successfully deliver high quality software while deriving impressive business benefits for their customers.

Confidential - Kenilworth, NJ

Business Analyst

Responsibilities:

• Responsible for defining the scope and implementing business rules of the project, gathering business requirements and documentation.
• Experience as a configuration administrator to protect web applications using CA Single Sign On.
• Part of the team developing the business use cases/system use cases using the RUP Methodology and processes for Logical Data Model and Physical data Model.
• In the analysis and design phase dealt with data architectural team to assist in understanding the functional requirements, technical requirements documentations and design of logical and physical data models.
• Prepared Logical Data Models using ERWIN that contains set of diagrams and supporting documents containing the essential business elements, detailed definitions, and descriptions of the relationships between the data elements to analyze and document business data requirements.
• Part of the Architecture data management team to ensure the process is done correctly with other business analysts, data architecture team, and technical teams.
• Designed, deployed and supported highly available and scalable Ping federate infrastructure in AWS and On-premise that provides single-sign-on (SSO
• Created different users, roles, Document libraries, Form Libraries, Team sites for projects, Issue Lists on SharePoint Server 2003
• Analyzed Business Requirements and segregated them into high level and low-level Use Cases, Activity Diagrams / State Chart Diagrams using Rational Rose according to UML methodology thus defining the Data Process Models.
• Understand the As Is system and develop the To Be system concept and also prepare the System Process Maps.
• Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data within the Oracle database.
• Excellent experienced in data Extraction, Transformation and Loading ETL using various tools such as SQL Server Integration Services SSIS, DTS, Bulk Insert and Bulk Copy Program utility, SQL Replication
• Data transfers from text files and Access databases using BCP and DTS; Data mapping and transformations while loading data using VBScript.
• Assigned tasks among development team, monitored and tracked progress of project following Agile methodology.
• Created Process Flow diagrams, Use Case Diagrams, Class Diagrams and Interaction Diagrams using Microsoft Visio and Rational Rose.
• Wrote Test Cases and performed User Acceptance Testing, documented the in detail defects using the Defect Tracking report.
• Used Test Case distribution and development reports to track the progress of test case planning, implementation and execution results.
• Created Use cases, activity report, logical components and deployment views to extract business process flows and workflows involved in the project. Carried out defect tracking using Clear Quest

Confidential, Chapel Hill, NC

Business Analyst

Responsibilities:

• Interacted with clients to gather all requirements to formulate business specifications and translate those into application functionality, decide when to advocate and when to compromise to arrive at a mutually acceptable solution.
• The project/s involved various development, enhancement, production and R&D support activities connected to clinical microbiology.
• Used Rational Requisite Pro to improve the communication of project goals, enhance collaborative development, reduce project risk and increase the quality of application before deployment.
• Involved in assessing 21CFR part 11 requirements and evaluate the organization’s current validation state.
• Contributed to the preparation of Master validation test plan, relevant to the components involved in maintenance of electronic documents in accordance with 21CFR PART 11 regulations.
• Responsible for managing activities and deliverables for all study conduct partners (Site Management Organizations, Pharm Sci, CROs, Vendors and etc.)
• Gathered and documented requirements for Pharmacy benefit managers (PBMs) for health insurance carriers
• Coordinate distribution of SOPs to Pharm Sci.
• Participated in meetings to establish and enforce SharePoint best practices and standards manage proper security group naming conventions & security assignment processes.
• Established standards and guidelines to be used in the areas data access, stored procedure development, ETL processing
• As part of CRM Activities, gathered client data, managed, tracked and analyzed this data to improve customer relationships and targeted marketing campaigns and pricing along with Marketing Team.
• Performed Gap Analysis by identifying existing technologies, documenting the enhancements to meet the end-state requirements.
• Assisted the technical team in translating application functionality into application architecture and the production of a System Functionality document.
• Involved in mentoring specific projects in application of the new SDLC based on the RUP, especially from the project management, requirements and architecture perspectives.
• Worked as “Tech Support” for end users to assist them with Remedy and Test Director during UAT testing phase.
• Performed Regression Testing with QTP.
• Conducted FRS (regulatory) and URS reviews and walkthroughs with the designers, developers and stakeholders.