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Sr Business Analyst Resume

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Bridgewater, NJ

SUMMARY

  • Over 8+ years of extensive experience as Senior Business Analyst in Pharmaceutical domain, Software Validation, Laboratory Information Management Systems (LIMS).
  • Experience in validating Laboratory Information Management System (LIMS), Adverse Event Reporting System (AERS), and Chromatography Data System (CDS).
  • Extensive knowledge of QMS, including Deviations, CAPAs, Change Controls and implementation of documentation to support Computer Systems operations.
  • Experience on Platform in LIMS - LabVantage & LabWare that includes Support, Implementation, Configuration and maintenance of master data elements in both Production and Pre-Production.
  • Skilled in implementing Clinical Trial Management System (CTMS) and Electronic Data Capture (EDC) in the clinical research environment.
  • Knowledge of FDA 21 CFR Part 11, 210, 211, 820 and ISO 13485 for medical and pharmaceutical industries.
  • Has in - depth knowledge of Software Development Life Cycle (SDLC) methodologies, assisting and working as Scrum Master on several projects, vast experience working in Agile, Waterfall, RUP methodologies. Primarily in Agile methodology. Handling Scrum team offshore and onsite.
  • Excellent experience in working with FDA regulated environment, GxP (GCP/GLP/GMP) guidelines.
  • Experience in Veeva CRM and Veeva Vault Content Management applications.
  • Excellent experience in implementing SaaS applications such as Veeva Vault.
  • Thorough knowledge of Change Control Management Activities, Back-up and Structured Change Control Procedures.
  • Expertise in implementing the agile, Rational Unified Process and Waterfall Methodologies throughout the Software Development Life Cycle of the project.
  • Strong experience writing Test Plans and Test cases using requirements, use cases and design documents.
  • Comprehensive knowledge and extensive experience in technical writing of Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Validation Master Plan (VMP), SOP’s, Test Summary Report, Test Plans, Test scripts, and Requirement Traceability Matrix (RTM) in FDA regulated environments.
  • Experienced in configuring Veeva applications using Veeva custom settings, Veeva messages, zvod fields and section signals on page layouts, offline validation rules, sample management Functional.
  • Functional experience with concentration on Use Case Modeling using UML, Business Process Modeling, Data Modeling, Change Management, Technical Training, Software Development methodologies, QA testing, and Systems Testing interfaces, Reports, Letters.
  • Highly collaborative team player with extensive Customer Relationship Management (CRM) skills, also possess excellent facilitation and mentoring skills and ability to prioritize tasks according to business needs.
  • Expertise in Project Planning, Project Design, creating functional specifications and data flow diagrams.
  • Experience in working with Microsoft Office suite (word, excel, Access, Visio, Power Point and Outlook) for documentation, analysis and presentation.
  • Experience working along with testing team in executing and maintaining Test Scripts, Review and documenting system and implementation Test Strategy Documents for Parallel Testing and System Integration Testing.
  • Extensive experience in Data Analysis and ETL Techniques for loading high volumes of data and smooth structural flow of the data.
  • Experience in Power BI, Tableau and other data visualization tools.
  • Experienced in Data Migration from other applications to Salesforce using Data Loader.
  • Strong SQL skills to perform business analysis and testing on SQL databases.
  • Proficient in Test driven development & testing methodologies for performing UAT, System Integration testing (SIT), Business Acceptance Testing (BAT) and documenting test results.

PROFESSIONAL EXPERIENCE

Confidential, Bridgewater, NJ

Sr Business Analyst

Responsibilities:

  • Involved in all stages of PDLC phases staring from Idea generation to research, development, testing analysis and introduction.
  • Created Validation plan for Laboratory Data system and Computer Systems (CDS, SDMS, ELN) interfaced withLIMS.
  • 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 implementing and maintaining a GxP compliant QMS.
  • Involved in designing, Implementing and supported as well as worked with Facilities Management on new Data Acquisition Laboratories installation projects in support of R&D.
  • Developed business and system requirements, program functions, best practices (GMP, GLP), FDA validation, and 21 CFR Part 11 conditions in a highly regulated environment, for submission of regulatory documents.
  • Defined and documented business process flows for Global Laboratory Information System (LIMs) LabVantage implementation pertaining to drug development.
  • Managed data work streams in support of the Veeva CRM, including but not limited to the addition of lead card and suggestion modules within Veeva CRM.
  • Involved in managing and participated in configuration and design of LabVantage LIMS and various lab Applications.
  • Responsibilities include leading business requirement definition, translation of business requirements into SFDC terminology, and Service Cloud solution design review to ensure business requirement fulfilment.
  • Worked on project life cycle and SDLC methodologies including RUP, RAD, Waterfall and Agile.
  • Responsible for gathering & understanding business requirements, design, development, testing and support for Veeva Vault, Promomats.
  • Reviewed tools for LIMS decision support to be used by the site. Analysis of LIMS enhancements, troubleshooting issues, second tier application support and routine master data configuration as required with in the LabVantage LIMS application.
  • Involved in developing custom solutions and interfaces leveraging the Salesforce-Veeva platform with agile.
  • Conducted project kick off meetings with team members to explain roles / responsibilities, relationships with other groups, deliverables, timelines, assignments and status reporting.
  • Actively involved in creating and updating the templates for the different folders and eCRFs in each application based on phase IV trials from CTMS.
  • Defined and documented business process flows for Global Laboratory Information System (LIMs) LabVantage implementation / upgrade.
  • Validated of LabVantage Laboratory Information Management System (LIMS) to be used by Quality Management group to store project related regulatory and non-regulatory documents in a controlled Manner.
  • Involved in Functional, Positive, Negative, and Regression testing of Workstation/Equipment automation withLIMS.
  • Conducting Internal Audits for each department and related processes to ensure the adherence toQualityManagementSystem(QMS).
  • Reviewed User Requirements to create Validation Plan and define the validation strategy, Roles and Responsibilities and all deliverables required for Validation of LabVantage LIMS.
  • Configured laboratory information management systems, such as LabVantage SQL LIMS, developing validation master plans and validating LIMS implementations.
  • Managed all Business Objectives, Requirements, and Specifications Requirements in SFDC
  • Implement CTMS to centralize all trial-related information, and improve clinical data management by equipping staff, including biostatisticians and database administrators.
  • Requirements Elicitation, Analysis, Communication, and Validation according to Six Sigma Standards.
  • Integrated Data from wide range of sources including in-house clinical data management systems, labs and contract research organizations and perform data cleaning.
  • 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.
  • Involved in testing LabVantage LIMS system in which is a Laboratory Information Management System involving functional and user-acceptance testing.
  • Prepared presentation slides in MS Project, which was extensively used in different JAD sessions and to track progress.
  • Involved in preparing the compliance report featuring the existing status of the cGLP, cGMP sensitive computerized systems.
  • Prepared FDA/Regulatory Readiness Reports for IT supported GMP systems that included SDLC documentation assessment, Training completion assessment, Physical and Logical Security, Change Control, Deviations, Disaster and Recovery Planning.
  • Validation and implementation of Idea screening procedures/ Writing of SOPs.
  • 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.
  • Participated in requirement gathering sessions with business stakeholders in capturing the requirement and technical feasibility with Veeva responsible for capturing, analyzing, and designing of different integration points involved in the system with external systems.
  • Designed and developed Use Cases, Activity Diagrams, Sequence Diagrams, OOAD using UML and Business Process Modeling.
  • 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.
  • Prepared test scripts for User Acceptance Testing (UAT).

Confidential, Indianapolis, IN

Business Analyst

Responsibilities:

  • Conducted user interviews, gathered Requirements, analyzed the Requirements and managed changes using Rational Suite.
  • 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.
  • Documented User Requirements from users and prepared Functional Requirement documents for various laboratory systems.
  • Authored installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) deliverables for Labware LIMS.
  • Involved in validation ofLabwareLIMSby developing, executing and documenting SOPs, Test Plans and Test Scripts.
  • Created Functional, Technical specifications and use cases for new CTMS Reports.
  • Conducted technology comparison, tool/solution assessment and solution selection from several potential solutions, including SharePoint, Clinical Trial Management System CTMS and customized.
  • Worked with project manager, SMEs and assisted with the implementation of the Labware LIMS
  • Worked with Data Warehouse team 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.
  • Performed 21 CFR Part 11 GAP Analysis, Risk Analysis, Developed Requirements, Traceability Matrix (RTM) to track requirements for the software application module. ValidatedLabwareLIMSto meet 21 CFR Part 11 FDA Regulations.
  • Responsible for validating variousLabwareLIMSfeatures such as like Labstation, Instrument Manager, Folder Manager,BusinessReports and Standards and Reagents Manager.
  • Developed SOPs in Pharma logistics, clinical mobile web applications, business operations, shipping, and delivering.
  • Involved in producing Clinical trials data / Drug safety data migration logics, rules, codes, and process. Provide documentation on the internal controls related to systems, operating environment, application and security.
  • Responsible for gathering & understanding business requirements, design, development, testing and support for Veeva Vault eTMF, Promomats, Medcomms, RIM implementations.
  • Worked with CTMS to support day-to-day operations in areas such as conducting study feasibility, streamlining the workflow of the trial coordinators and investigators.
  • Analyzed business requirements and segregate them into Use Case Diagrams, Activity Diagrams, Sequence Diagrams, and OOD using Borland Together according to UML methodology thus defining the Data Process Models.
  • Worked on Data requirements, identified data sources, determined the content of data fields and created Data Mapping Documents and performed Data Extraction using SQL queries.
  • Participated in performing and communicating Risk Assessment pertaining to Labware LIMS validation to the quality team and higher management.
  • Involved in re-designing Labware LIMS application to combine the requirements for three LIMS systems in effort to increase user satisfaction and productivity, without increasing resources.
  • Created procedures for Labware LIMs system and work with Operations to implement.
  • Conducted a CSV audit and prepared a position paper for ensuring compliance for all SOX and GxP servers and applications being migrated to one of three central locations as part of a data center consolidation, and presented findings to all levels of management.
  • Involved in design and implementation of enhancements to GxP project within RIS (Radiologically Isolated Syndrome) Preclinical department using WatsonLIMS and Crystal Reports.

Confidential, PA.

Business Analyst

Responsibilities:

  • Gather requirements by conducting meetings and brainstorming sessions with end users and SME and document them using Requisite Pro - the documentation tool offered by Rational.
  • 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.
  • Generated Statements of Work for the Design and Implementation of CRM solutions based on Salesforce.com Methodology.
  • Defined charter, scope, schedule, and resources for projects productizing R&D programs, managing (and often defining and delivering) customer needs via marketing requirement documents (MRD) and product requirement documents (PRD) with program milestones, user documentation and QA, increasing profitability while building a best practices organization.
  • Custom tools upgrade client had created marketing tools to support their custom web application which needed to be re-architected to work with ATGs ecommerce suite.
  • 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.
  • Developed and executed validation guidelines for testing the GMP, GCP, GLP sensitive transactions.
  • Created the configuration document for custom setup for various user groups such as HR, marketing, R&D & sales, research analyst & investigators.
  • Administration of Clinical R&D software including Oracle clinical, Clinapps PMD, Forecasting and sales and marketing software Spotfire and Cognos.
  • Assigned tasks among development team, monitored and tracked progress of project following Agile methodology.
  • Create and maintain data model/architecture standards, including master data management (MDM).
  • Gathered requirements and modeled the data warehouse and the underlying transactional database
  • Perform Gap Analysis of the processes to identify and validate requirements.
  • Gathered Business/Functional Requirements from Business/R&D Users.
  • Created 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.
  • Responsible for integrating with Facets. Designing test scripts for testing of Claims in Development, Integration and production environment.
  • Use Cases and other Process Flow Models were designed using Visio and Rational Rose
  • Managed the whole testing process using Mercury Interactive Test Management Tool Quality Center.
  • Performed UAT and exposure to User Certification Testing (UCT) and Operational Readiness Testing (ORT)
  • Organize 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.
  • Gather final requirement and draft the BRD and Business Data Flow Diagrams
  • Established traceability matrix using Rational Requisite Pro to trace completeness of requirements in different SDLC stages.
  • Defined Functional Test Cases, documented, Executed test script in Facets system
  • Worked with Claims, enrollment, eligibility verification for members and providers, benefits setup, and backend payment cycle in facets.
  • Review the Test Plan developed by the testing team for testing the application.
  • Assist the QA personnel in the creation of Test Cases using Rational Test Manager.

Confidential, Greenville, NC

Business Analyst

Responsibilities:

  • Played an active role in gathering, analyzing and writing Business Requirements.
  • Worked throughout the SDLC, which included requirements, specifications, design, analysis and testing utilizing Agile methodology.
  • Collected and documented Business Processes as well as Business Rules.
  • Involved in developing and executing IQ, OQ and PQ protocols, prepared the VSR to summarize all the documentation and instrument validation activities
  • Created templates for method validation protocol, method validation report, standard test method.
  • Gathered URS and FRS for the Chemstation Software and its integration with LabWare LIMS.
  • Assisted in initiating and conducting Gap Analysis and Remediation Plan for lab equipment and software interfaced with LIMS for 21 CFR Part 11 compliance and prepared Deviation Reports.
  • Prepared specification documents for Labstation module of LIMS and created test scripts for positive, negative, regression and the validation of Labstation module for interfacing lab instruments with LIMS Lab Ware.
  • Provided key input in working with users in defining project and system requirements.
  • Assisted in building a business analysis process model using Rational Rose and Visio.
  • Documented the Functional Specifications Document using UML.
  • Create and evolve the Salesforce Marketing Cloud strategy and coordinate go to market efforts.
  • Participated in JAD sessions between the end users and the development team.
  • Involved in developing and maintaining programs in SAS for UNIX in a user support environment.
  • Developed timelines for project delivery and managed projects and resources to successful completion.
  • Conducted project related presentations and provided reports to the higher management.
  • Conducting user interviews at both in-house and client locations, gathering and analyzing requirements using Agile and requisite pro.
  • Actively participated in developing test procedures and test cases to perform manual testing on DSM LIMS.
  • Assisted in preparing the Validation Report using the Advance Reporting tool incorporated in the DSM LIMS package.
  • Performed functional testing and integration testing on the new releases of the application.
  • Wrote several complex queries to retrieve data from Oracle and was checked for data integrity.
  • Validated the DSM LIMS against FDA 21 CFR 11 rules.
  • Performed Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data
  • Was responsible for identifying and documenting Business rules, created detailed Use Cases and conducted User Acceptance Tests.
  • Was responsible for indexing of the tables in that data warehouse.
  • Develop Logical and Physical data models that capture current state/future state data elements and data flows using Erwin.
  • Used Quality Center for updating the status of all the Test Cases; Test Scripts that are executed during testing process.
  • Evaluated testing results for each potential release build using Quality Center, Quality Center and Bugzilla reports, listing summarized bug information in priority sequence, recommended viability of release for production.
  • Involve in preparing Trace Matrix to design test cases
  • Preparing Weekly action report; QA feedback to QA team; Manager.
  • Interacted with the Helpdesk team to investigate and resolve production issues for assuring quality standards of the product.

Confidential - New York

Business Analyst

Responsibilities:

  • Wrote documentation for all aspects of the computer systems validation lifecycle, in accordance with FDA regulations, particularly CFR 21, part 11, Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ).
  • Used SQL for extracting data from the Oracle database and performed data analysis.
  • Maintained and updated reports, templates extract from business intelligence tools (databases, dashboards, Oracle, SAP).
  • Performed stakeholder analysis through RACI matrix. Also worked inXML, SQL Server, JIRA, Salesforce, Transformations inXML.
  • Worked with business stakeholders and R&D team to define project scope, gather requirements, define & improve processes, and implement global Clinical and Medical Affairs solutions for handling research data and patient records.
  • Used LCM for migration and version control of Reports and Dashboards between environments DEV/QUAL/PROD.
  • Managed upgrades for Pharma R&D IMs O/S (AIX, UNIX, and Windows) environments and oversee the successful migration of system data migration requirements.
  • Involved in designing and implementing statistical report processes for regular data collection and clinical data analysis. Analyzed Phase I, II and III Clinical Trials.
  • Create User Requirements Specifications document for CTMS and for Investigator database component of CTMS.
  • Gathering and documenting business requirements; going above and beyond to understand the client& complete business needs for Labware LIMS and Emerson Syncade (MES) Integration project.
  • Addressing remote DBA support using remote connection, chat support; ticketing support (L3/L4).
  • Involved in overseeing the Oracle installation on UNIX environment and Oracle internals as L3/L4 support.
  • Worked on receiving Encounter files from their PBM Pharmacy Benefit Manager, verifying the data content by transactional analysis.
  • Involved in PBM in corporate complete Member Enrollment and Eligibility check, Drugs Prescription, Plan design, claim adjudication and Verification, Call chain, Rx enquiry, Clinical requests handling etc.
  • Involved in developing SOPs for archival and retrieval procedures from RX claim to CRx claim (Catalyst Rx Library) and also deployed documents and reports on server using MS Share Point.
  • Providing required training sessions to the team on QMS standards, polices and Agile/Scrum principles and techniques by playing an Agile coach role as needed.
  • Implemented the Quality Audit to verify the check list whether we met the QMS standards and procedures.
  • Responsibilities in this position involved the successful conversion of acquired company ERP systems with Confidential ’s custom platform and Confidential MES custom system.
  • Involved in conducting User Acceptance Testing (UAT) by managing identified issues and ensured all issues were resolved.

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