SUMMARY

• 8+ years of experience as a business analyst with strong expertise in Pharmaceutical and Healthcare industry with extensive experience in requirement gathering for custom solutions in cross functional areas like pre - clinical research, clinical research, Pharmacy Benefit Management, MMIS and Electronic Medical Health Record (EMHR).
• Extensive experience in analyzing and writing system functional specifications including use cases.
• Good experience of Veeva Vault(ETMF, CTMS, RIM Suite, Submission and Submission Archive).
• Broad knowledge of GxP (Pharmaceutical manufacturing, Biotech, Medical Devices and Life Sciences).
• Proficient in all the phases of System Development Life Cycle (SDLC) - Analysis, Design, Development, Testing and Documentation of software applications.
• Exercised proficiency in eRequester & JIRA to monitor technical, infrastructure and service issues, as well as billing issues.
• Proficient knowledge in executing Operational Qualification for various components of LabVantage LIMS by utilizing in-house and vendor test scripts.
• Expert level understanding of project life cycle and SDLC and also RUP, RAD, Waterfall and Agile methodologies.
• Good experience in working with Clinical Trials Databases.
• Strong knowledge of Agile PLM, scrum processes and experience in redesign of product development process as per the business requirement.
• Experience on LIMS configuration, implementation, LIMS Master data, LabWare LIMS to meet site requirements.
• Expertise in Metadata Management, Data Profiling & Quality, Data Governance and Master Data management (MDM).
• Experience in preparation of business requirement documents (BRD), Use cases, UML, Process Flows (BPM), Test Plans, Test cases, Data Mapping etc.
• Experience in analysing of LIMS enhancements, troubleshooting issues, second tier application support and routine master data configuration as required within the LabVantage LIMS application.
• Proven success as a business analyst through the years, providing a well-balanced understanding of business relationships, business requirements, and technical solutions.
• Experience in Test Data reviewing and executing detailed Test scripts for UAT, analyzing bugs, interacting with team members in fixing errors and User Acceptance Testing (UAT) and also assisted in post -production support.
• Strong understanding of information technology capabilities and dependencies, including platforms, content management, e-document strategies and process mapping.
• Extensive experience in writing, reviewing and enhancing the validation deliverables (URS, FRS, Design document, IQ, OQ, PQ) for LabWare LIMS.
• Proficiency in LabVantage architecture and functionality.
• Strong knowledge of FDA QS 21 CFR 820, 211 for Pharmaceutical and Life Science Industries and cGMP, GCP, GLP, CAPA, GRP.
• Extensive experience in coordinating the efforts, tracking and acting as the liaison between customer SME's, management, development and supplier s on major PLM deployments.
• Comprehensive Experience in coordinating, drafting and executing efforts of MES-LIMS interface functional test document involving SAP QM and LabWare LIMS.
• Excellent skills in forming and facilitating Joint Application Design (JAD) sessions for eliciting data requirements that support the business requirements and documenting data flows.
• Comprehensive experience in Agile and RUP Business Process Modeling.
• Strong Working Knowledge of SDLC, GRC 21CFR Part 11 and software FDA validation practices.
• Proficient with data migration (ETL development), document data manipulation processes and scripts.
• Experience in Clinical Trial using SCRUM development methodology handling highly sensitive data.
• Extensive working knowledge in validating systems like Inventory management, LIMS, CMS and EDM.
• Proficient in Technical and Business Writings, Business Process Flow, Business Process Modeling, Business Analysis and Testing various methodologies.
• Experienced in executing validation guidelines for testing the GMP, GCP, GLP sensitive transactions.
• Excellent knowledge in developing and evaluating business process Models.
• Experience in validating Adverse Event Reporting System (AERS) and Chromatography Data System (CDS).
• Good Exposure to Query Analyzer, Execution Plan to optimize SQL Queries.
• Strong problem solving skills, troubleshooting L3 Production issues on Learning Management System and LMS Data Mart & Reporting system.
• Proficient in MS Office Excel (pivot tables, vlookups, hlookups, macro), MS Access, MS PowerPoint, MS Visio.
• Proficient in developing and reviewing of various documents including the Software Requirement Specifications (SRS), Standard Operating Procedures (SOP), Business requirements document (BRD), Use Case Specifications, Functional Specifications (FSD), Systems Design Specification (SDS), Requirement Traceability Matrix (RTM) and testing documents.
• Effective in executing multiple tasks and assignments ahead of schedule. Created and maintained effective budgets.
• Exposure to Client/Server, Web Application developmental tools and Software development and design.
• Demonstrated ability to identify root causes of problems, consider both the long and short-term impact of proposed solutions and develop workable solutions.
• Extensive Experience in Enterprise Document Management System EDMS with automated systems such as Documentum and GXPharma.

PROFESSIONAL EXPERIENCE

Confidential, Houston, TEXAS

Sr. Business Analyst

Responsibilities:

• Work with business stakeholders to document business needs for the RFP package.
• Drafted new SOPs and trained all users on the systems, implications and impact of 21CFR Part 11 compliant data systems on day-to-day functions.
• Reviewed system validation documentation, including Validation Plans, Risks Assessments, Qualification Protocols (IQ/OQ/PQ), URS/FRS, Test Scripts, Trace Matrix, and Final Summary Reports.
• Arranged meetings with the Client to understand the business requirements.
• Worked with introductory stage planning/development of managed CRM solutions for Field Marketing Organizations (FMO) on Microsoft Dynamics CRM.
• Partnered with clients/scientists/technical groups to perform quality reviews on business requirements in order to verify that the requirements accomplished the demands of the end users.
• Gathered and documented requirements for integration between Product Lifecycle Management (PLM) solution and legacy system.
• Map the overall as-is business processes for each data source system in scope of the project.
• Involved in design and implementation of enhancements to GxP project within RIS (Radiologically Isolated Syndrome) PreClinical department usingLabWareLIMS, WatsonLIMS and Crystal Reports.
• Designed and developed Use Cases, Activity Diagrams, Sequence Diagrams, OOAD using UML and Business Process Modeling (BPM). Executed UAT test cases for OBI using HPQC and Veeva system.
• Involved in development of Clinical Trial Management System (CTMS) integrated with EMR and customized to suit protocols following CDISC, GCP and other FDA standards.
• Created procedures for Labware LIMS system and worked with Operations to implement.
• Responsible for documentation of all aspects of the Computer System Validation Life Cycle deliverables in accordance with 21CFR Part11 and Good Laboratory Practices.
• Created Source to target data mapping documents identifying key data elements and prepared Data Flow Diagrams.
• Participated in configuration of Labware LIMS and various lab applications for the Genetic Quality.
• Worked with Oracle Support in analyzing and identifying root cause for Agile PLM issues.
• Worked in formulating the test plan ensuring that the test matrix covers all the requirements, and validated the expected results in systems testing.
• Supported other team members to validate/qualify TrackWise, LIMS, ELN and Lab Equipments, etc.
• Worked on desiging, implementing and validating 21 CFR Part 11 compliance strategies for Labware LIMS.
• Worked with Data Warehouse in the development and execution of data conversion, data cleaning and standardization strategies and plans as several small tables are combined into one single data repository system MDM (Master Data Management). Also created targeted Questionnaires for SMEs to gather requirements.
• Worked in ETL environment involving Informatics/Data Stage and Business Intelligence tools like Cognos, Business Objects. Initiated Requirement gathering, analyzing, validating, and authoring use cases usingUML.
• Involved in development of a structured change management approach and methodology with limited direction
• Created Process Flow diagrams, Use Case Diagrams, ER Diagrams, Class Diagrams and Interaction Diagrams using Microsoft Visio and Rational Rose.
• Performed the requirement analysis, impact analysis and documented the requirements using Rational Requisite Pro.
• Documented validation transfer plans for four separate assays while collaborating with Marketing, R&D and Manufacturing. Also gathered requirements for Clinical Operation on Veeva Vault.
• Worked with project managers and assisted with the implementation of the LIMS software in compliance with the FDA 21 CFR Part 11 requirements, using GAMP guidelines.
• Involved in mentoring specific projects in application of the new SDLC based on the Agile Process.
• Worked with the business consultants and Labware consultants to develop the complex LIMS reports for environmental monitoring on CLS.
• Analyzing the ETL process created in Informatica, developed SQL queries and tables which replicated the ETL, and compared the SQL results with the Informatica tables.
• Involved in creating business processes and modeling diagrams using Rational Unified Process (RUP).
• Initiated and facilitated successful project kick-off meetings for Change Management.
• Drafted 39 page policy paper about the importance of R&D, innovation and reimbursement levels for biologics.
• Worked under the guidance of the PMO Board, coordinated with various business units and departments (Chemistry, Biology and Chromatography) and assisted in the procurement, selection, design and configuration of proposed Laboratory Information Management System (LIMS) to ensure optimal operational performance.
• Documented various artifacts as per the FDA 21 CFR Part 11considerations as well as Good Manufacturing Practices (GMP). Also Validated LabWare LIMS to meet 21 CFR Part 11 FDA Regulations.
• Worked with key members from various cross-functional teams to analyse various third-party CRM solutions to make a ‘buy vs. build’ decision. Conducted cost/benefit and impact analysis.
• Wrote notes and action items during corporate strategy meetings and monthly R&D, Internal & External Pipeline, Generic, & Consolidated Finance meetings.
• Managed requirement definition & testing workshops with multiple vendors.
• Served as a resource for analytical services utilizing SQL Server, and TOAD/Oracle.
• Responsible for gathering & understanding business requirements, design, development, testing and support for Veeva Vault eTMF, Promomats, Medcomms.
• Created and updated Validation Plan, Installation Qualification IQ Protocol, Operation Qualification OQ Protocol, Performance Qualification PQ Protocol, Test Scripts, System Testing Summary, User Acceptance Testing UAT Summary, Traceability Matrix and Validation Summary to assure user requirements and functional requirements are satisfied in the system.
• Interacted with Business Unit members for gathering data, information and requirements related to enhancing pharmacy claims and Medical, Lab and Radiology Reports.
• Involved in defining scope and creating project baselines for the Change Management Component.
• Created traceability matrix to ensure that the requirements are traced to the test cases.
• Involved in the analysis, design and automation of client/ server applications using Oracle and SQL.
• Ensured that extremely thorough, effective and organized test process is implemented and delivered the highest quality product.
• Evaluated and compared different potential solutions for laboratory data management.
• Worked along with Data Analyst in using T-SQL, Access, and SQL to manage the integration of large data sets and data technology.
• Worked closely with the project team in planning, coordinating and implemented QA methodology on various phases of the application.
• Analyzed results of Regression Testing as performed by Testers using QTP and held meetings with Developers and Testers. Run the SQL queries using TOAD and SQL Navigator.
• Involved in implementation of Learning Management System (LMS), estimated effort based on the requirements, and followed all effective SDLC processes for its customization.
• Interacted with the developers to report and track bugs using Test Director.
• Extensively involved in creating and executing IQ and OQ test scripts to verify sample inventory, sample transaction and e-signature capturing functionality, etc.

Confidential, The Woodlands, TEXAS

Technical Business Analyst

Responsibilities:

• Created a Traceability Matrix to maintain the Traceability of the requirements.
• Served as a team interface for business interaction and responsible for proper channeling of their requirements to match organizational capabilities and ensuring client satisfaction along with an end to end understanding of Processes for Clinical Trial legacy Systems.
• Conducted user interviews, gathered Requirements, analyzed the Requirements and managed changes using Rational Suite.
• Configured laboratory information management systems, such as LabVantage SQL LIMS,developing validation master plans and validating LIMS implementations.
• Worked with the Master Data Maintenance teams to maintain multiple sets of supply chain master data (SAP).
• Worked with Data Warehouse in the development and execution of data conversion, data cleaning and standardization strategies and plans as several small tables are combined into one single data repository system MDM (Master Data Management).
• Recommended LabVantage LIMS as a Global solution to address analytics and help reduce the amount of time and errors with the manual entry of assets and inventory management data into the new system to support web, desktop and mobile development.
• Applied the concepts of Business Process Engineering (BPE) and Business Process Reengineering (BPR) to enhance the auditing process.
• Prepared and updated Requirements Specification documents, Traceability Matrix, IQ scripts and OQ scripts as per the Amgen guidelines to be in compliant with FDA regulations.
• Conducted interviews with end-users to collect requirement and business process information.
• Implemented data access, storage and validation routines on the database server using Procedural Language/Structured Query Language (PL/SQL).
• Developed business process models in RUP to document existing and future business processes.
• Researched and revised documentation in various formats for client’s LiquidChromatographs (LC) and MassSpectrometers (MS) systems.
• Initiated the GAP analysis with clients, stakeholders and trading partners going over requirements, capturing action items and providing appropriate solutions to complete associated tasks incurred.
• Prepared and documented System Requirements and workflows for the Content Management Application tool.
• Performed extensive Requirement Analysis including data analysis and gap analysis.
• Validated the Chemistry Laboratory Information Management System (LIMS) for compliance with FDA regulations.
• Created user stories, test scripts and reviewed test results within JIRA.
• Used JAD sessions and one-on-one meetings to identify Business and System Requirements and documented then using Use Case Modeling, Process Flow diagrams and documentation, data mapping rules, and Screen mock-ups.
• Participated in various stages of data and requirement analysis for project needs.
• Identified internal and external system requirements, design and configuration set-up, also created User Documentation and conducted training classes.
• Developed business requirement specification documents as well as high-level project plan.
• Performed daily support for the customized LIMS for bug fix and enhancement request.
• Designed and developed Use Cases, Activity Diagrams, Sequence Diagrams and OOD using UML. Documented and delivered Functional Specification Document to the project team.
• Reviewed User Requirements to create Validation Plan and define the validation strategy, Roles and Responsibilities and all deliverables required for Validation of LabVantage LIMS.
• Involved in PLM integrations like performing delivery, legacy data analysis, cleansing, mapping and migration.
• Worked with database team to define database requirements and load procedures for successful Business Objects reporting. Created transition requirements document to allow users to be familiar with new CTMS System.
• Assumed ownership of Use Case Diagrams, Use Case narratives and other various artifacts.
• Coordinated various kinds of User Acceptance Testing (UAT) including regression testing, system testing, integration testing, functional testing, alpha & beta testing.
• Worked with the Project Manager to develop both high-level and detailed application architecture to meet user requests and business needs. Relieved pressure off the PM by maintaining artifacts and portions of the project binder.
• Participated in the logical and physical design sessions, assisted and developed high and low level design documents. Also designed project document templates based on SDLC methodology.
• Worked with the Project Manager in performing Risk Assessment, Management and Mitigation.
• Actively involved in defining and designing the Data Acquisition, Transformation, and Data Cleansing approach for the MDM implementation.
• Worked with user testing of systems, developing and maintaining quality procedures, and ensuring that appropriate documentation is in place.
• Documented business and technical requirements gathering for the development of MDM, Data Warehousing and Reporting implementation roadmaps.
• Performed task decomposition, delegated tasks and monitored project milestones using MS Project. Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data within the Oracle database.

Confidential, Atlanta, GEORGIA

Business Analyst

Responsibilities:

• Gathered requirements by conducting meetings and brainstorming sessions with end users and SME and document them using Requisite Pro - the documentation tool offered by Rational.
• Involved in verifying accuracy of billing information and codes before processing Medicare and Medicaid forms.
• Actively involved in data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data within the Oracle database. Also extensively involved in data modeling.
• Involved in HIPAA/EDI Medical Claims Analysis, Design, Implementation and Documentation.
• Assisted in development of test cases based on functional requirements for Institutional and Professional claims for EDI and HIPAA Transactions 837/835, 834, 276/277, 270/271 testing.
• Worked on Medicaid and CHIP program requirements, including complete end to end life cycle data flow of eligibility, enrollment, claims, encounters, payment and post-payment.
• Involved in preparing the Test Case Scenarios for Health Care Claim Payment/Advice.
• Performed Gap Analysis of the processes to identify and validate requirements.
• Prepared and analyzed AS IS and TO BE in the existing architecture and performed Gap Analysis.
• Identified/documented data sources and data transformation rules required populating and maintaining data warehouse content.
• Analysis of inbound and outbound interfaces and extensions to FACETS claims processing system.
• Involved in all phases of the development and implementation of an Enrolment Resolution and Reconciliation process for health insurance exchanges.
• Responsible for troubleshooting and resolving errors in 834 and 820 transactions for health insurance exchanges and performing root cause analysis.
• Analyzed HL7 transmissions and monitored Interoperability and interface connectivity.
• Created workflow scenarios, designed new process flows and documented the Business Process and various Business Scenarios and activities of the Business from the conceptual to procedural level.
• Validated the following: 837 Health Care Claims or Encounters, 835 Health Care Claims payment/Remittance, 270/271 Eligibility request/Response, 834 Enrollment/Dis- enrollment to a health plan.
• Organized requirements into high level Use Cases and low level Use Case Specifications and modeled them into UC, Activity and Sequence Diagrams using Rational Rose and MS Visio.
• Applied UML notations and methodology in developing models that accurately represent the business process and workflows and clearly communicate them to the stakeholders.
• Involved in development, quality assurance and maintenance work on the Child Support Enforcement System.
• Worked on Medicaid and Children's Health Insurance program (CHIP) requirements, including complete end to end life cycle data flow of eligibility, enrollment, claims, encounters, payment and post-payment.
• Worked along with the QA personnel in the creation of Test Cases using Rational Test Manager.
• Used Electronic Medical Record (EMR) to extract useful information regarding patients for claim submission.
• Facilitated JAD sessions involving the management, development and user teams for clarifying requirements and facilitating better communication.
• Involved in various Facets Data models like Gateway, Claims, Membership, Provider, Billing, Capitation, Invoice, Benefits, Product and Plan.
• Involved in the full HIPAA compliance lifecycle from GAP analysis, mapping, implementation, and testing for processing of Medicaid Claims.
• Created various reports such as billing payment reports, Billing Grouping Payment and discount reports & Worked on false positives claims by analyzing rejected claims and evaluated Medicare requirements and benefits in Medicare Health Plans for member enrollment and management.
• Coordinated and prioritized outstanding defects and enhancement/system requests based on business requirements, allowing sufficient time frame to ensure accuracy and consider deadlines.
• Reviewed the Test Plan developed by the testing team for testing the application.
• Involved in performing version control and defect tracking activities using Rational ClearCase and Rational ClearQuest.

Confidential, Edison, New Jersey

Business Analyst

Responsibilities:

• Gathered requirements by conducting meetings and brainstorming sessions with end users and SME and document them using Requisite Pro. Also defined Functional Test Cases, documented, executed test scripts
• Performed UAT and exposure to User Certification Testing (UCT) and Operational Acceptance Testing (OAT).
• Gathered Business/Functional Requirements from Business/R&D Users.
• Extensively involved in data modeling Advisor to the criminal justice agencies stakeholders on the best practices.
• Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data within the Oracle database. Also gathered final requirement and draft the BRD and Business Data Flow Diagrams.
• 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.
• Converted EDM business initiatives into multi-year data management plan for this leading maker of biomedical devices. Also wrote functional requirements for the company’s PBM software system.
• Created the configuration document for custom setup for various user groups such as HR, marketing, R&D and sales, research analyst and investigators.
• Assigned tasks among development team, monitored and tracked progress of project following Agile methodology.
• Involved in creating and maintaining data model/architecture standards, including master data management (MDM). Also gathered requirements and modeled the data warehouse and the underlying transactional database.
• Actively involved in creating Data Stage jobs to extract, transform and load data into data warehouses from various sources like relational databases, application systems, temp tables, flat files etc.
• Involved in developing program functions, best practices (GMP, GLP), FDA validation, and 21 CFR Part 11 conditions in a highly regulated environment, for submission of regulatory documents pertaining to drug development.
• Use Cases and other Process Flow Models were developed using MS Visio and Rational Rose
• Worked on the testing process using Mercury Interactive Test Management tool Quality Center.
• Organized requirements into high level Use Cases and low level Use Case Specifications and modeled them into Use Case, Activity and Sequence Diagrams using Rational Rose and MS Visio.
• Responsible for the coordination of the quarterly Veeva Align project plan.
• Worked with IT and business areas to support Veeva enhancement requests, incidents and Service Requests.
• Established traceability matrix using Rational Requisite Pro to trace completeness of requirements in different SDLC stages. Also performed Gap Analysis of the processes to identify and validate requirements.
• Reviewed the Test Plan developed by the testing team for testing the application.
• Assisted the QA personnel in the creation of Test Cases using Rational Test Manager.

Confidential, Rancho Cucamonga, CALIFORNIA

Business Analyst

Responsibilities:

• Worked with the account managers, managements, and report requestors to gather requirements, get report requests. Extensive use of Excel to create Functional Specification Documents & Templates.
• Wrote Business Requirements, analyzed them and tested them.
• Interacted with the ETL team, developer(s), management, and account holders to get the requirements, document them, design templates, and write specifications.
• Designed Functional Specification Documents for the reports. Worked with ETL team during the upload process.
• Analyzed trading partner specifications and created EDI mapping guidelines.
• Designed the process flow diagrams for flow of information and report creation process.
• Conducted RAD sessions for the report users, requestors, and the developers.
• Documented all the changes in the initial templates and was responsible for Release Management.
• Coordinated with the developer, on day-to-day basis, during the development process.
• Prepared Need Analysis Documents of the requirements gathered through JAD sessions.
• Prepared and analyzed AS IS and TO BE in the existing architecture and performed Gap Analysis. Created workflow scenarios, designed new process flows and documented the Business Process and various Business Scenarios and activities of the Business from the conceptual to procedural level.
• Used MS Visio to create Flow diagrams and Use Case Diagrams.
• Created presentations explaining the entire report development process, while drawing a comparison between the legacy & the new report.
• Created Test Scripts & Test Scenarios to check report content, layout and parameters.
• Tracked the defects in legacy reports as per account managers and end users. Compared the results and tracked the differences in excel
• 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).
• Helped with Data Mapping between the data mart and the Source Systems.
• Worked with SQL queries using MS Access for data manipulations. Worked as a liaison between the Business and Technology Department. Enhanced communication lines between executives, managers, and peers.