SUMMARY

• Over 8+ years of professional experience as a Business Analyst in the Healthcare, Pharmaceutical, Biotech and Medical Device industries.
• Multi - skilled Life Sciences professional with progressive experience in the Laboratory, Project Management, Operations Management, Leadership, Data Management and Customer Relations
• Working knowledge about policy Underwriting, Binding, Rate making rules and factors affecting it, Rewriting and Worker's Compensation. Good understanding of Object-Oriented Analysis and Design (OOAD)
• Through knowledge about financial services and financial instruments.
• Comprehensive knowledge of Software Development Life Cycle (SDLC) and various methodologies such as Agile, RUP, Waterfall.
• Experience in working in close proximity with business users, project stakeholders, Subject Matter Experts (SMEs) and staff to understand high level business requirements and minute level specifications for new applications, and to modify existing applications.
• Adept in performing GAP Analysis to check the compatibility of the prevalent system infrastructure with new business requirements.
• Life Sciences operations knowledge in Clinical Trial Management and Pharma Sales & Marketing industry.
• Proficient in Requirements Gathering, Surveys/Questionnaire Development, business Requirement Documents (BRD), Functional Requirement Specifications/Documents (FRS/FRD)
• Extensively experienced at convening Joint Requirement Planning (JRP) sessions with business User Groups, conducting Joint Application Development (JAD) sessions with IT Groups, and Conflict Management.
• Exceptional in creating screen mock-ups, wire frames, User Interface/Graphic User Interface (UI/GUI), context diagrams, business process flows, and in developing Use Case Diagrams, Behavior Diagrams (Sequence Diagrams and Activity Diagrams) based on the UML Methodology.
• Well versed in analyzing CRM business processes that include Forecasting, Campaign management, Lead Management, Role Hierarchy, Territory Management, Order Management,
• Experienced in Software Development Life Cycle methodologies (Waterfall Model, Iterative, Agile SCRUM)
• Extensive experience on the appropriateness of the data requirements and coordination with MDM Product Management and MDM Data Governance on final requirement decisions.
• Great knowledge on data analysis skills and good understanding on structure of the required data within the MDM source and within MDM and documented and informed to other MDM stakeholders
• Quality Assurance experience in formulating and reviewing test plans, test scripts, test requirements, test cases, test reports, and adept in using defect-tracking tools to address issues as required by the project.
• Using knowledge and ability to execute projects using various Software Development Life-Cycle (SDLC) methodologies - Waterfall, Iterative, Agile (Scrum/Kanban), provided Agile Coaching and transition/transformation from full SDLC Waterfall to 100% Agile.
• Actively participating in Post Production Validation (PPV), production support, and handling of issues.
• Expert in tracking and managing requirements through Requirement Traceability Matrices (RTM)
• Handling Change Management by conducting Impact Analysis & facilitating Change Control Board (CCB) Meetings.
• Excellent technical skills in SQL to extract, transform and loading data to the database using tools such as Guidewire Data hub.
• Proven track record in project execution, end-to-end project delivery, and refinement and enhancements using various iterative models within the stipulated time, resources, and cost constraints.
• Experience in conducting Joint Application Development (JAD) sessions with end-users, expert team, development and QA team for project meetings, walkthroughs and customer interviews.
• Expert in Root Cause Analysis, Feasibility studies and Risk Assessment studies.
• Experienced in creating tableau dashboards, worked with different types of data visualization charts in tableau.
• Expertise in GUI testing, Functionality testing, System testing, Unit testing, Integration testing, Front end testing, Back-end testing and Regression testing of Client/Server and Web based applications
• Demonstrated capability in managing people, leading teams on various complex projects.
• Experienced in writing System Use Case Specifications, Object Oriented Analysis and Design, Change management, Risk Management, Workflows and Unified Modelling Language (UML) diagrams, Web Portal Content Management.

PROFESSIONAL EXPERIENCE

Sr. Business Analyst

Confidential, Round Lake, IL

Responsibilities:

• Fully responsible for requirements gathering and documentation.
• Involved in Organizing and conducted extensive JAD sessions with users to identify, understand and document requirements.
• Involved in Validating the System in Accordance with 21CFR Part 11.
• Involved in Creating use case narratives to record Subscription business rules.
• Involved in Implementing SDLC which included requirements specifications, design, analysis and testing.
• Led implementation of CRM, CLM, and Contracting modules for Market Access Team.
• Gathered requirements, conducted User Acceptance Testing (UAT), and delivered training. Partnered with Marketing and content development agencies to reduce amount of time, costs, and resources across Brand Teams.
• Wrote Use Cases, prepared use case diagrams (using Rational Rose) and followed Rational Unified Process at every stage of the process.
• Used Agile and Rational methodology in the project development for Rational Test Suite for various phases of RUP.
• Brainstormed visualizations, involved in developing backend data in Alteryx and created front end in Tableau.
• Provided technical Expertise on the use of Rational Clear Case, Rational clear quest and Requisite pro, which were used for Data archiving and Requirements Management.
• Involved in preparing test plan and test cases based on functional requirements using Rational Test Manager.
• Dealt with data mapping issues between various source systems and staging area and data-marts.
• Worked and coordinate with MDM Product Management and MDM Data Governance on final requirement decisions.
• Leading Data Management of Alexion HCP/HCO MDM (Veeva Network)
• Organized daily/weekly conference calls with franchise stakeholder to discuss opening market values, trade activities, and NAV (net asset value) by maximizing our internal CRM tool CSX.
• Implemented changes to targeting, alignment, and CRM capabilities to support launch of Contract Sales Organization (CSO) team that doubled sales capacity. Contributed to restructure/realignment of sales territories; delivered training & on-going communications for entire sales team
• Produced functional specifications and led weekly meetings with developers and business units to discuss outstanding technical issues and deadlines that had to be met.
• Assisted the Senior Business Analyst in writing Functional Requirement Specifications (FRS) and User Requirement Specification (URS).
• Involved in Developing test plans and test cases according to business requirements.
• Maintained Test Matrix with the test results obtained.
• Managed data source purchase agreements, migration, and integrations for MDM. Optimized HCP data sources and frequency of data refresh.
• Identified Actors, Activities, Artifacts and Workflows and developed use case diagram using Rational Rose.
• Participated in Automated regression and Non-Functional test plans
• Met with client groups to determine requirements and goals. Utilized Rational Unified Process (RUP) to configure and develop process, standards, and procedures and create a Business requirement Document.
• Responsible for preparing Software Requirement Specification (SRS) and documenting them.
• Involved in Creating Process Work flows, Functional Specifications documents and documented system requirements.
• Provide implementation assessment, strategy, and mentoring services for Rational Rose, UML and RUP.
• Interacted with various cross-functional teams on building business use cases, and understanding expenses and revenue stream.
• Working with clients to better understand their needs and present solutions using structured SDLC approach.
• Interaction with the developers to report and correct bugs.
• Involved in developing the systems implementation project management plan with milestones and steps from procurement of vendors to project implementation and maintenance.
• Followed a structured approach to organize requirements into logical groupings of essential business processes, business rules, and information needs. Ensured that critical requirements are not missed.
• Aided management in standardizing web applications by preparing GUI standards and recommending alternatives for in corporation in a phased, iterative manner.
• Interacted with client and the Technical Team for requirement gathering and translation of Business Requirement to Technical specifications.
• Assumed ownership of Use Case Diagrams, Use Case narratives and other various artifacts.
• Relieved pressure off the PM by maintaining artifacts and portions of the project binder.

Confidential - Rahway, NJ

Business Analyst

Responsibilities:

• Conducted JAD sessions for communicating with the all-Project Managers and stakeholders.
• Worked as an Interface between the users and the different teams involved in the system development.
• Gathered requirements from all project stakeholders to verify and validate the business requirements using elicitation/gathering techniques like interviewing questionnaires, brainstorming, and focus groups; project meetings, reviews walkthroughs customer interviews and coordinating various technical and managerial teams at all levels
• Carried out GAP analysis to prepare As-Is and To-Be state of the system/application post feature implementation by preparing business process flow diagrams.
• Involved in UML standards like Use case diagrams, Activity and Swimlane diagrams using MS Visio and Lucid Chart. Conducted Prototype demos, wireframes and walk-through sessions.
• Wrote Use Cases to precisely document the flow and function of specific UI and system features.
• Prepared business requirements document (BRD) for the analyzed feature and conducted
• Concurrent with on-boarding of CSO team, developed outbound inside sales capability using Veeva CRM.
• Developed Test Plans, Test Cases and Test Script and worked with CRM, MDM systems. walkthrough sessions with various stakeholders for approval and sign off.
• Used the Office Suits extensively which included MS Word, MS excel, MS Access, MS Visio also Smartsheet for various documentation and analysis reports.
• Experienced with different life sciences disease codes. Experience with policy administration systems. Medical malpractice by providers which the treatment provided falls below the accepted standard of practice.
• Coordinated in design phase Data Mapping with team for FSD and worked on CDM, LDM& PDM.
• Organizing UAT activities like strategy, Planning, Designing and Training sessions.
• Worked closely with QA team for identify and prepared Test case scenarios, Test Cases and test data based on business process.
• Report defects in test management tool and manage them throughout their lifecycle using JIRA.
• Built community of ISV and SI partners charged with implementing the Microsoft Life Sciences vision.
• Prepared UAT End of test Report and provide Business Readiness Support and Training sessions.
• Creating and updating Project Plans, Weekly status reports and closure reports.
• Managed Approved E-mail content development and integration into Veeva CRM.
• Utilized corporation in developing Agile SDLC methodology. Used Scrum Work Pro and Microsoft Office software to perform required job functions.
• XML is used extensively to communicate with web service component and to populate data at the client side
• Involved in mentoring specific projects in application of the new SDLC based on the Agile Unified Process, especially from the project management, requirements and architecture perspectives.
• Involved in Creating RUP activity diagrams and sequence diagrams to analyze the requirements and recommend solutions.
• Assisted the technical team in translating application functionality into application architecture.
• Clarified QA team issues and reviewed test plans and test scripts developed by QA team to make sure that all requirements will be covered in scripts and tested properly.
• Gathered business requirements by interviewing the Subject matter experts (SMEs), conducting JAD sessions with stakeholders and documented them in a format that could be reviewed and understood by both business and technical teams.
• Performed as a business and technical analyst by translating user requirements into practical/integrated process-based solution
• Attended trainings such as EDC-Rave, Oracle Argus Suite and Electronic Document Management Systems (EDM), Change Management and Control, Validation with respect to a specific project
• Good experience using Microsoft SharePoint for document management and as a common repository for project documents and deliverables.
• Utilized Share Point document management system to share documents and to interact.

Business Analyst

Confidential - Lyndhurst, NJ

Responsibilities:

• Worked extensively with MS Excel and MS access.
• Conducted review sessions on regular basis with QA and development teams for preparing status, delivery report and client reporting.
• Accumulated system requirements from various departments through surveys and interviews.
• Involved in Creating UAT plans with several test cases for each project to ensure that the system runs smoothly after the proposed enhancements or changes have been made.
• Suggested measures and recommendations to improve the current application performance.
• Involved in Creating high quality functional requirement specifications and supporting documents for business systems.
• Involved in gathering business requirements from the end users and management.
• Wrote test scripts for User Acceptance Testing (UAT).
• Interview screening and evaluation of numerous applicants for various Clinical IT and IT related positions in the organization.
• Involved in Developing the project plan with assistance from the management, and included provisions for project scope changes and issues and initiated efforts to make improvements.
• Restructuring Configuration management database (CMDB) in ASID as business need.
• Simplified asset management approval process by integrating Veeva PromoMats with CRM.
• Proficient in working with systems such as ServiceNow CC, managing Change Request as closing successfully.
• Involved in gathering business requirements from the end user and management with the validation for business system ServiceNow CC implementation.
• Involved in Creating RUP activity diagrams and sequence diagrams to analyse the requirements and recommend solutions.
• Involved in Creating specifications for data cleansing and conversion programs, EDI sales data loading processes and procedures, mapping of client/territory alignments and hierarchies.
• Assisted PM in Developing Project plan and tracking project Process, Scheduling and organizing group meeting, as well as involved in developing Risk Management Plan
• Involved in Designing the business requirement collection approach based on the project scope and SDLC methodology.
• Used SDLC (System Development Life Cycle) methodologies like the RUP and the waterfall.
• Prepared scenarios, Use Cases & UML State Diagram for scenarios using Rational Rose.
• Develop validation deliverables for integration of IoT system to Bayer's CRM service application
• Prepare presentation slides in MS Project, which was extensively used in different JAD sessions and to track progress.
• Assisted the technical team in translating application functionality into application architecture.
• Participated in the bug review meetings, updated requirement document as per business user feedback and changes in the functionality of the application.
• Clarified QA team issues and reviewed test plans and test scripts developed by QA team to make sure that all requirements will be covered in scripts and tested properly.
• Organized meetings to discuss outstanding issues with QA and developers.
• Wrote test scripts for User Acceptance Testing (UAT).

Business Analyst

Confidential - Morrisville, NC

Responsibilities:

• Worked on Validation of Legacy Systems in compliance with 21 CFR Part 11.
• Involved in writing the standard operation procedures and safety precautions to be taken for proper handling of analytical instruments like UV spectroscopy Atomic Absorption spectroscopy, Raman spectroscopy, Fourier Transform Infrared Spectroscopy (Fluorometer), Microplate Reader, HPLC, GC and TOC Analyzers.
• Complete 21 CFR Part 11 compliance assessments of laboratory and manufacturing systems
• Validated computerized laboratory equipment like Atomic Emission Spectroscopy (automated in process equipment) based on GAMP 4.
• Managed implementation of Document Management System meeting requirement deadlines.
• Proposed solutions to reporting needs and develop prototypes using SQL and Business Objects that address these needs.
• Responsible for business requirements gathering and technical requirements analysis and documentation for File Net-based document management system
• Managed change control procedure for the customization of legacy laboratory instruments.
• Understanding and leveraging SFDC CRM processes for help with pre-sale activities.
• Conducted quality review of existing documentation and validation plans, test scripts, and summary reports both pre and post execution
• Spearheaded multiple projects in an Agile environment to deliver Amazon Alexa Skills and Google Home Actions for several Pharmaceutical, Life Sciences & B2B Publishing clients.
• Performed dry run and peer run of the authored test scripts to detect deviations and fix the bugs as part of quality review.
• Hands on experience in writing Requirement Traceability Matrix, SOP's, Work Instruction, Risk Assessment.
• Documented user-friendly compliance reports for installation qualification, operating qualification and performance qualification validation protocols (IQ, OQ, PQ) in agreement to FDA standards
• Involved in preparation of documents for Computer systems validation documents in accordance to 21CFR, part 11.
• Setup an Interface between the laboratory instruments and the Open LAB ECM for data acquisition, compliance documentation, storage, retrieval.
• Worked directly with strategic partners, and internal ecosystem management teams, to implement Conditions of Satisfaction (COS) and Account Plans for the Life Sciences partner ecosystem.
• Acquiring all the lab data electronically at its source and a full complement of instrument interfaces.
• Performed user acceptance testing to the check the various functionalities of LIMS.
• Involved in writing and executing test cases and test scripts to validate certain functionalities of LIMS
• Performed GAP analysis of business requirements (Client) to vendor requirements. Assessed vendor documentation
• Facilitated JAD sessions with SMEs and business analysts from other feeder systems for a detailed analysis and a better understanding of impact of various projects on each other.
• Involved in Creating functional requirement documents for the impacting projects
• Involved in Creating UAT plans with several test cases for each project to ensure that the system runs smoothly after the proposed enhancements or changes have been made
• Coordinated with Business and IT team for the preparation of validation deliverables
• Prepared Requirements Traceability Matrix (RTM) and drafted Validation Summary Report (VSR)
• Worked under tight timelines without extensive support
• Involved in Designing and developing Use Cases, Activity Diagrams, Sequence Diagrams, and OOD using UML.

Confidential - New York, NY

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.
• Used ISI Toolbox Pharma Edition efficiently for FDA submissions.
• Involved in Developing the project plan with assistance from the management, and included provisions for project scope changes and issues and initiated efforts to make improvements.
• Negotiated and finalized Clinical Trial Agreements, Contract Research Organizations (CRO) agreements, General Service Agreements, Consultancy Agreements and Lab Services.
• Involved in Analyzing data, created data dictionary, data mapping document and mapped their relationship to develop taxonomy per data domain.
• Involved in Creating wireframes and screenshots for the application to easily communicate it to the CRO using MS Visio to assist development and engineering in understanding the requirements.
• Worked on project life cycle and SDLC methodologies including RUP, RAD, Waterfall and Agile.
• Wrote PL/SQL statement and stored procedures in Oracle for extracting as well as writing data.
• Integrate Data from wide range of sources including in-house clinical data management systems, labs and contract research organizations and perform data cleaning.
• Requirement gathered from R&D, clinical trial data, scientist, research associate, regulatory affairs, sales and marketing, medical library.
• Extensively worked with Case Report Forms (CRF) during database design and developed various macros to filter data for phase II and phase III of clinical trials.
• Extracted data from disparate sources by SAS/ACCESS.
• Worked with data modelers for source to target data mapping and help in creation of logical and physical data model
• Involved in Creating wireframes and screenshots for the application to easily communicate it to the CRO using MS Visio to assist development and engineering in understanding the requirements.
• Conducted global teleconferences with Clinical, Regulatory, Quality Assurance, and CRO Teams, troubleshot/resolved supply chain, import/export, clinical GCP, and regulatory issues, and assured manufacturing quality and integrity.
• Participated in the bug review meetings, updated requirement document as per business user feedback and changes in the functionality of the application.
• Clarified QA team issues and reviewed test plans and test scripts developed by QA team to make sure that all requirements will be covered in scripts and tested properly.
• Organized meetings to discuss outstanding issues with QA and developers.
• Wrote test scripts for User Acceptance Testing (UAT).