PROFESSIONAL SUMMARY:

• Sr. Business Analyst professional with 6+ years of track record in requirements gathering, performing gap analysis, data analysis and document between 'As - is' and 'To-be' processes in pharma domain.
• Knowledge of 837, 835, 277, 270, 271, NCPDP and experience in implementation of HIPAA and NCPDP standards. Experience in reviewing all SDLC documents, protocols and SOP's to ensure they meet GxP and FDA regulations
• Excellent experience in applying FDA regulations to the aspects of the Computer and Lab Systems. Abundant experience in generating and reviewing Computer Systems Validations CSV Deliverables according to 21 CFR Part 11 and FDA regulations for the Pharmaceutical industries
• Proficient in documenting System Requirement Specifications (SRS), Functional Requirement Specifications (FRS), Requirements Traceability Matrix (RTM)using Rational Requisite PRO and Software development plan
• Skilled at gathering requirements by conducting one on one interviews, brainstorming sessions and Joint Application Development (JAD) sessions.
• Excellent Business writing skills in writing project documentation such as: Business Requirements Document (BRD), Functional Requirement Document (FRD), and Use Case Specifications.
• Demonstrated ability to document business processes and write detailed functional requirement document (FRD) or business requirement Specification (BRS), Software Requirement Specification (SRS) and Use Case Specification.
• Experienced in preparing process documents like Project plan (Scheduling and maintain the project timeline (Project planning/ tracking)), change request tracking, Project status report, Project issues and risk mitigation plan / reports.
• Technically competent professional with rich experience in Designing prototype (GUI) of the application, web or mobile application wireframes. Blueprint of the prototype / application were designed using MS Visio and MS Office.
• Wrote SQL queries to extract related data from transaction record database for OLAP purposes. Extensive Experience with data analysis including data modeling, data mapping and data validation.
• Having working experience in SQL and Oracle Databases. Having involved in Full Implementation Life Cycle of the application (SDLC) and in post implementation support using Agile Methodology (Scrum Framework), Waterfall.
• Effectively tested, logged and managed defects found during project system testing, functional testing using BRD with different browser for web applications and validating outputs generated.
• Validating data, mobile web services on various devices and platforms for mobile apps. Proficient in developing UAT plans, UAT cases, executing UAT. Skilled in training end user and ensure readiness of the user for UAT and train the trainer.

SKILL:

Methodologies: OOAD, Waterfall, RUP, Agile, UML, SDLC, JAD, Six Sigma, CMM, RAD, SCRUMOperating Systems Window, UNIX

Change Management Tools: Rational Clear Quest, Test Director

Business Modeling Tools: Rational Rose, Requisite Pro, Clear Case, Clear Quest, Microsoft Visio

Project Management: MS Office Suite, MS Project, MS Visio

Databases: MS SQL server, MS Access, Oracle, RDBMS Concepts, Database DevelopmentVersion Control Systems Rational Clear Case, PVCS

Web Technologies: HTML, XML, Adobe Photoshop, Adobe Light room, Dreamweaver, Flash

PROFESSIONAL EXPERIENCE:

Confidential, Berlin, CT

Sr. Business Analyst

Responsibilities:

• Provide guidance and direction to ensure adherence with Company quality and customer service standards, clinical initiatives, ethical business practices, and ensure business unit goals are aligned with national and global Company objectives.
• Develop and implement programs, action plans, educational materials, policies, and procedures based on best practices collaborating with field teams to c-level stakeholders and vendors to improve the lives of those we serve through the utilization of technology.
• Serve, as a liaison between business and technical teams translating technical/architectural specification into relatable business needs in the development of applications, databases, and reports.
• Worked in Scrum/Agile methodology and created/prioritized product backlog items for MITA & EDW. Worked on PBM, NCPDP, Specialty Pharmacy, COB’s etc. including Mail Order Pharmacy
• Project Manager facilitating technical and educational acquisition efforts converting electronic health data, human resource applications, SharePoint migration, other corporate technical resources, and the creation of audit tools while maintaining the integrity of all data, minimizing the impact to resources, patient care and billing processes.
• Elicitation and analysis of business requirements for software development, writing BRD/FSD, completing clinical data flow mapping from Liberty Dialysis to FMS systems for over 2,500 employees and 100,000 patient record., working with MIQS vendor, performing UAT, leading cross-functional teams virtually to feed and maintain the integrity of all data during conversion process, operating according to FTC rulings.
• Supported and educate end users with Epic clinical applications and associated clinical and operational workflows. Conducted User Acceptance Testing for Business Objects Reporting for eQRMS GxP Reports, GxPChange Control
• Reviewed documents of URS, FRS and DS in accordance with FDA regulations, particularly 21 CFR Part 11 and GxP regulations.
• Supported and approved all clinical system enhancements, following complete SDLC/product workflows from inception to completion assuring all stakeholders’ business needs were met or exceeded.
• Liaised between multiple development teams and business user groups to create an enterprise wide e-scribe solution streamlining and improving patient medication management and medical staff compliance. Wrote User Stories along with Acceptance Criteria as a part of the AGILE methodology
• Prioritized requirements and resolved Clinical Services helpdesk tickets documenting in Remedy Ticketing and HP Quality Center meeting 100% of weekly goal. Wrote scripts for knowledge base to assist internal clients in faster technical resolutions.

Confidential, Berkeley Heights NJ

Business Analyst

Responsibilities:

• Responsible for supporting divisional and clinical level educators in the use of Company EMR (CMS certified MIQS), document imaging methods, LMS, Kronos, ADP, Microsoft Office Suite, SharePoint, intranet, and associated applications.
• Assist the Liberty Divisional Educator/Quality teams in evaluating the educational needs of their staff and provide the resources to meet those needs.
• Ensure patients receive safe and effective dialysis treatment; the clinic meets the new Conditions of Participation found in the Federal Register at 42 CFR Part 494 (Subpart A-Subpart D; sections 49 .180 ) and; to ensure the clinical staff comply with all policies and procedures.
• Project managed and provided business system analysis for acquisitions and new clinics in major software and system implementation and conversions, directing training in all company systems including Microsoft Outlook, EMR, HR onboarding, SharePoint, clinical education, clinical policy and procedure implementation, ESRD network communications, CMS CROWNWeb and NHSN notifications and tracking, ensuring regulatory compliance through entire process.
• Developed and maintained all operational and technical flows using Visio and Power point and worked on Specialty Pharmacy, mail order pharmacy, COB, Formulary, claims etc.
• Wrote and edited over 100 clinical and technical policy and procedures for existing, startup and acquisition use including document controls utilizing Access database, Excel, and SharePoint
• Collaborate with vendors in maintaining compliance in reporting metrics to CMS through process mapping, QA, UAT and system implementation.
• Developed BI solution using SharePoint and Microsoft Excel, tracking facilities progress in appropriately registering and participating in CMS required programs, NHSN (infection reporting) and CROWNWeb.
• Streamlined access and facilitated consistent reporting at the facility level by working with ESRD Networks and staff to implement a national standardized form for patient data collection and reconciliation reducing administrative level of effort.
• Authorized operational compliance trending reports utilizing SharePoint custom lists feature reducing the amount of rejected claims.
• Supported multiple physician practices during acquisitions and regulatory changes in writing sustainable best practice reports and educating professionals on documentation relative to CMS Quality Payment Program (QPP)
• Implemented electronic documentation strategies to ensure internal quality improvement activities were monitored and reportable leading to a 98% initial Department of Health survey passing rate.
• Worked extensively and individually with department leads to elicit requirements and identify business needs, designing, developing, testing and deploying custom built SharePoint sites providing training for all users.
• Update and implement standardized format and content for Liberty Dialysis Patient Handbook and Patient Admission Forms in English and Spanish distributed enterprise wide.
• Partnered with HR to implement new onboarding program to include tracking Patient Care Technician certification status as required by CMS.
• Developed, published, and implemented nationwide staff development programs, organized and led webinars to provide updates on company systems and policy and procedures to include open line Q & A session

Confidential, Ocala, FL

Business Analyst

Responsibilities:

• Performed Requirement Gathering & Analysis by actively soliciting, analyzing and negotiating customer requirements and prepared the requirements specification document for the application using MS Word.
• Identify GAP in various business processes. Conduct discussion sessions with various business owners and redefine business processes for the new POS system.
• Create and communicated the prototype requirements to the development team in Excel formats as templates for the reports.
• Abundant experience in generating and reviewing Computer Systems Validations CSV Deliverables according to 21 CFR Part 11 and FDA regulations for the Pharmaceutical industries
• SMEs (Subject matter Experts), reported owners to recommend processes for new implementation of (GxP) or (non-GxP) Cognos Reports. Worked with FDA guidelines (21CFR Part 11), HIPAA (Health Insurance Portability and Accountability Act).
• Responsible for maintaining the change notification request document and communicating with the developers in each iteration review meetings.
• Worked on workflows, scalability and capacity panning requirements for Adobe AEM authors. Requirement gathered from R&D, clinical trial data, scientist, research assosiate, regulatory affairs, sales and marketing, medical library.
• Proficient in developing Use case scenarios to enable design and development of applications using tools like Rational Requisite Pro, JIRA and VersionOne based on the SDLC methodology.
• Performed as an enterprise MDM subject matter expert. Responsible for delivering customer information systems across North America and Canada. Took responsibility for integrating variety of data systems, and geographically fragmented customer information.
• Understand the business and number of transactions per day and Design and ease the POS interface screen for quicker sales transaction and to print out daily X & Z reports
• Extract data from business intelligence system and generate reports for planning/MDM, manufacturing and other areas of the supply chain.
• Implement new methods to replenishment inventory based on sales pattern, Min-Max, Days of Inventory, Inventory replenishment based on actual sales and manual order entry
• Prepare weekly dispatch schedule based on the order cycle and availability of product, use local transportation companies to set up XDX at warehouse for faster delivery from wholesaler to retail store.
• Involved with QA team to define the test plan and test cases for new application also perform Functional integration testing for the system.

Confidential, Miami, FL

Business Analyst

Responsibilities:

• Defined accountability procedures governing data access, processing, storage, retention, reporting and auditing measuring contract compliance
• Assist with managing all facets of project life cycle, including design, development, testing, and deployment.
• Support Data and Analytics/Transformation Architecture teams who are building a data strategy aligned with global strategic direction - develop canonical and other models as required, implementing data architecture platforms and solutions and data services, develop MDM foundation, participate in the design and implementation of unified data warehouse; must be able to implement end to end solutions in support of the various data tracts and work streams
• Developed the Stone Soup Pharmaceutical Data Model. Assisted on the development of a proposal for a major client.
• Involved in project scope meetings with the Pricing manager to understand the type of requests and issues handled by the pricing team and documented the high level business requirements to the product backlog using JIRA.
• Led development and documentation of data governance policy and procedures as well as Stewardship inventory and control set up processes for MDM projects
• Created, formatted and edited multiple Drug Master Files, FDA Product Approval applications, FDA, CVM (Centre of Veterinary Medicine), ICH, GCP, GMP, Regulations and guidelines.
• Supported and educate end users with Epic clinical applications and associated clinical and operational workflows. Conducted User Acceptance Testing for Business Objects Reporting for eQRMS GxP Reports, GxPChange Control
• Implemented metadata standards, data governance and stewardship, master data management, ETL, ODS, data warehouse, data marts, reporting, dashboard, analytics, segmentation, and predictive modelling