SUMMARY

• A skilled Business Systems analyst with 8+ years of experience in the Biopharmaceutical and Life Sciences domain.
• Extensive experience in SDLC project/product management,business and data analysis,business process analysis and improvement, requirements elicitation, documentation, team management, QA and UAT Management, and user support.
• Expert in creating Business Requirement Document (BRD), Functional Specification Documents (FSD), gap analysis, cost benefit analysis, Use Case Diagrams, Sequence Diagrams and Activity Diagrams.
• Worked on a database driven web based CTMS solution for tracking regulatory and clinical data in a clinical trials environment.
• Experience in validating Laboratory Information Management System (LIMS), Adverse Event Reporting System (AERS), and Chromatography Data System (CDS).
• Experience in creating complex Ad - hoc reports, Dashboard Reports, KPI’s, Business views containing charts showing U-Verse sales, products, posted installs, in-service customers, disconnects, revenue by regions, market areas & divisional managers using Toad, ERwin data modeller, Business Objects, Visual Studio, Reports and SQL.
• Familiar with the lifecycle and operations related to a Clinical Start Up Study.
• Expert level knowledge in all aspects of analytics/data warehousing solutions (Database issues, Data modeling, Data mapping, ETL, data migration and reporting solutions).
• Worked in different types of Projects such as CTMS Clinical Trial Management System and CDC Clinical Document Control
• Expertise in broad range of technologies, includingbusinessprocess tools such as Microsoft Project, MS Excel, MS Access, MS Visio, technical assessment tools, MicroStrategy Data Warehouse Data Modeling.
• Extensive experience with Data Warehousing, Extraction, Transformation and Loading (ETL) and Business Intelligence (BI) tools (Qlikview and Tableau).
• Working knowledge with IMS data Xponent, Xponent PlanTrak for plan level data and DDD for outlet level data.
• Experience in preparing and analyzing AS-IS and TO-BE in the existing architecture and performed Gap Analysis.
• Excellent experience in working with FDA regulated environment, GxP (GCP/GLP/GMP) guidelines
• Experience in performing Clinical Start Up Studies in compliance with Good Clinical Practice guidelines.
• Experience in Veeva CRM and Veeva Vault Content Management applications.
• Experience in data warehouses and data marts for business intelligence reporting and data mining along with developing and documenting process flows for business processes
• Excellent presentation skills using Microsoft PowerPoint, SAS Table, SAS Graph, and SAS Chart.
• Experience in SAS Administration skills, data warehousing and business intelligence
• Strong knowledge in working with batch files and ran SAS programs using UNIX shell scripts
• Responsible for Data extraction mining cleansing from several databases like SQL Server, Oracle and other external files using SAS Miner, SSIS
• Experience with various tools for planning, tracking and managing projects and requirements using Atlassian JIRA, Rally (CA Agile Central), MS SharePoint server and MS Project Professional.
• Experience in conducting JAD sessions with SME (subject matter experts), stakeholders, developers and end-user representatives to make sure all the stakeholders and developers are on the same page.
• Experience in Supply chain management, Business analysis & Modeling, Engineering, Manufacturing, Facility design & operations, Process Improvement, and Project Coordination.
• Expertise and hands-on experience in SQL for Analysis, Reporting and testing purpose.
• Very good experience on Veeva Vault (PromoMats and MedComms). Have created document types, workflows, roles, stages.
• Have experience in integrating Veeva Vault with Veeva CRM for various business requirements.
• Experience in Agile / Scrum methodology in writing user stories/epics and acceptance criteria using JIRA.
• Working experience in IMS Data - Dealt extensively with nrx new product sales, nrx dollars new product sales dollars, trx Total product sales and trx dollars Total product sales dollars
• Experience in writing and executing SQL Queries for Databases such as Oracle, and MySQL.
• Experienced in application 21CFR part 11, GxP and CSV guidelines.
• Experienced in creating Data Flow Diagrams, Use Cases, Use Case Diagrams, Activity diagrams, Entity Relationship Diagrams, Data Mapping, and Data Integration.
• Tracing requirements throughout the development process and verifying adherence using the Requirements Traceability Matrix (RTM)
• Expert level knowledge in planning, scheduling, monitoring and budgeting with experience in requirement gathering, gap analysis,riskanalysis, effort estimation etc.
• Expert level skills in analyzing complex data sets, performing ad-hoc analysis and data manipulation using Excel, Access, Teradata, SQL and SAS.
• Experience in creating reporting solutions using Teradata Views, Macros, Excel functions, Excel graphs and Pivot tables.
• Experienced in analyzingbusinessrequirements in all stages of SDLC methodologies such as Agile, Scrum, and Waterfall.
• Excellent knowledge of analyzing requirements for data migration, data reconciliation, mapping rules, staging rules and transformation rules for the ETL processes.
• Hands on experience in documentingBusinessPlans, Requirement Documents, Functional Specification Documents, Test Plans, Test Cases and Test Scripts.
• Proficient in performing Risk Assessment Techniques, Gap Analysis, Impact Analysis and preparing corresponding Remediation Plans.
• Proficient in facilitating and performing User Acceptance Test (UAT) by working with internal and external Users / Customers and obtaining delivery approval for the project.

PROFESSIONAL EXPERIENCE

Confidential, Miami, FL

Sr. Business Systems Analyst

Responsibilities:

• Involved in the computer system validation (CSV) lifecycle, which matches with FDA regulations particularly 21 CFR part 11 and validation requirements like reporting features, password regulatory rules, password aging and session time-out for theLIMSsystem.
• Involved in validation ofLabwareLIMSand OpenLab including editing and review of protocols and post execution review for IQ and OQ effort.
• Conducted operational testing ofLabwareLIMSsoftware and involved in writing of Operational Qualification of variousLIMSmodules.
• Collaborating with the QMO Manager to define and establish the appropriateQualityManagement System(QMS), based on project and client requirements; such as Capability Maturity Model Integration (CMMI), ISO 9001, Six Sigma, and Information Technology Infrastructure Library (ITIL)
• Worked with internal team, CROs and clinical sites to ensure the tracking and timely conduction of clinical studies.
• Documented Business Rules, Process flow diagrams, Content Analysis, Performance requirements and user guides.
• Assisted in developing the system requirements and design of a Documentum application that automated the process of takingCTMSgenerated documents and storing them as PDF
• 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.
• Extracted data from disparate sources by SAS/ACCESS.
• Re-writing the company'sQMSmanual, following new ISO 9001:2015 guidelines and requirements in order to qualify for the ISO revision.
• Assisted in developing statistical programs to perform clinical data analysis, review and approve results by using R, SAS and JMP
• Assured that all the validation documentation such as IQ, OQ, PQ are in compliance with cGMPs.
• Contributing with IT deliverables associated with project lifecycle and also performing data validation and process validation by executing SQL queries.
• Worked along with the lead on IMS Data - Information regarding top prescribers prescribing for specific plans and products belonging to specific territory and district were gathered, analyzed and used for sales marketing purposes.
• Performed data validation and loading of sales and marketing data warehouse.
• Demonstrate the capabilities of Veeva CLM on the extent to which existing functionality of the legacy system can be mapped in the new platform as well as the additional features that come out of the box in Veeva.
• Worked on Veeva CRM and Vault implementation
• Assisted in entering and updating Issues (Epics, Stories, and Tasks) onto JIRA Agile application.
• Performed Requirement Analysis to understand user needs for data Toxicology/ Pharmacology n-tier system.
• Involved in the analysis, design and automation of client/ server applications using Oracle and SQL.
• Creating data mapping specifications from the Data warehouse to SAS, Cognos and MicroStrategy datamarts.
• Analysed User Requirement Document, Business Requirement Document (BRD), Technical Requirement Specification and Functional Requirement Specification (FRS)
• Worked with Data Warehousing ETL Team and Business Intelligence team for effective reporting. Informatica was used for ETL and Business objects for reporting.
• Worked in compliance with FDA regulations and cGxP guidelines in all the aspects of Computer Systems Validation.
• Coordinating with multiple clinical departments IS Teams and vendors to gather requirements and implement application changes in support of department changes and new builds.
• Worked with Sales Marketing IMS Data Xponent Plantrak and DDD and IMS HCRS.
• Involved in writing SQL queries for checking the Data Migration, Data transformations and Database Integrity in Teradata.
• Conducted validation and configuration of LIMS module as per 21 CFR part 11 Compliance.
• Conducted manual testing like functionality, integration, system, positive and negative testing.
• Initiated and performed automated testing of AUT using Quick Test professional.
• From a Technical perspective, involved in various levels of troubleshooting within the application as well as at various levels of Clinical data, release engineering activities and branch planning, provided application and technical support to Clinical Start Up Studies.
• Created transition requirement document to allow users to be familiar with newCTMSSystem.
• Performed validation of laboratory equipment like GC/MS, HPLC, Spectrophotometer and Autoclave in compliance with cGxP guidelines.
• Involved in documenting the Validation Master Plan in accordance with FDA regulations, particularly 21 CFR Part 11, GLP and GMP.
• Communicated pertinent LIMS Requirements to site/system owners and gained consensus with management, IT, QA and scientists of departmental requirements.
• Involved in Identifying user Requirements and Analyzing the Existing Data Source and IMS data to Build Product Platforms into Standardized Data warehouse/Datamart.
• Identified, document business processes for LIMS and captured As-Is and To-be workflow process diagrams to illustrate exchange data between existing CDS and future LIMS.
• Conducted User Acceptance Testing and documented the UAT summary reports.
• Performed front end and back-end testing, GUI, functionality testing and regression testing on AERS using QTP.
• Maintained the requirements traceability matrix (RTM) and mapped the modified test cases as per the new requirements.
• Validated AERS to ensure 21 CFR Part 11, electronic records, electronic signatures and cGXP compliance testing.
• Ensured the tracking of incoming Case Report Forms (CRFs) prior to safety review and upon manual review.
• Participated in the design and review of protocols, documents, regulatory submissions and reports.
• Identified optimum combination of application solutions to meet the requirements of business functions (LIMS EDMS, CDS and Project Server).
• Coordinate testing efforts of external systems interacting with coreLabwareLIMSapplication
• Facilitated and documented the scientific content, its usage, business process standards and technical requirements.

Confidential, Tarrytown, NY

Business Systems Analyst

Responsibilities:

• Played an active role in gathering, analyzing and writing Business Requirements.
• Collected and documented Business Processes as well as Business Rules.
• Developed and executed IQ, OQ and PQ protocols, prepared the VSR to summarize all the documentation and instrument validation activities.
• Coordinating and tracking all projects for releases using Project Management System JIRA.
• Created templates for method validation protocol, method validation report, standard test method.
• Gathered URS and FRS for the Chemstation Software and its integration withLabwareLIMS.
• Assisted in initiating and conducting Gap Analysis and Remediation Plan for lab equipment and software interfaced withLIMSfor 21 CFR Part 11 compliance and prepared Deviation Reports.
• Assisted in designing setup/ build studies in Phase I III clinical trials, interpreted protocol using specified Legacy tool, like Trial Setups, Clin build, compare protocol utility tool to build the collector for data entry by sites to understand the concepts in designing the study design of the trial.
• Responsible for managing all data management activities such as requirement gathering, designing specification documents, eCRF designing, study set-up, edit checks, database, user acceptance testing, views deployment, quality checks required to support clinical trial process handling application issues.
• Worked on broad range of technologies, including business process tools such as Microsoft Project, MS Excel, MS Access, MS Visio, Data Warehouse and Data Modeling.
• 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.
• Executed UAT test cases for OBI using HPQC and Veeva system.
• Prepared specification documents for Lab station module ofLIMSand created test scripts for positive, negative, regression and the validation of Lab station module for interfacing lab instruments withLIMSLab Ware.
• Provided key input in working with users in defining project and system requirements.
• Assisted in developing SAS programming for extracting data from flat files, Excel spreadsheets and external RDBMS (ORACLE) tables using LIBNAME and SQL PASSTHRU facility.
• Worked with Data Providers to capture and integrate sales data for use in internal deliverables such as Field Reporting (Veeva), Incentive Compensation, Analysis and Targeting.
• Documented user and functional requirements for a healthcare professional HCP look-up tool between Veeva CRM and the third party IMS HCP database.
• Developed XML schema design for a web services solutions platform that delivers marketing services information to internal and external client applications.
• Collaborate with team and outside experts on UI/UX
• Implement CTMS to centralize all trial-related information, and improve clinical data management by equipping staff, including biostatisticians and database administrators.
• Developed SQL queries/Unix Shell Scripts / XML Schemas/ Files / SOAP web services and VB C# Scripts.
• Executed functional and end-to-end testing as required on GUI andMainframe applications.
• Worked with Information Architects (IA) and other representatives from the User Experience (UX) team to design wireframes, mock ups, mobile app prototypes and process flows.
• Worked on Business Intelligence reports development efforts by working closely with MicroStrategy, Teradata, and ETL teams
• Actively participated in preparing High Level Logical Data Models and BRD's (Business Requirement Documents)
• Worked with Documentum Enterprise content management (EDMS) using pharmaceutical GxP standards to capture, store, preserve and deliver content and documents related to organizational processes with Every Document Now Available (EDNA).
• Validated generated XML output with expected values with data sets.
• Documented the Functional Specifications Document using UML.
• Worked on SAS datasets like patient medical data, optimization of sas codes using indexing technique to increase the overall performance
• Participated in JAD sessions between the end users and the development team.
• Identified/documented data sources and transformation rules required populating and maintaining data warehouse content.
• Developed timelines for project delivery and managed projects and resources to successful completion.
• Conducting user interviews at both in-house and client locations, gathering and analyzing requirements using Agile and requisite pro.
• Assisted in preparing the Validation Report using the Advance Reporting tool incorporated in the LIMSpackage.
• 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 theLIMSagainst FDA 21 CFR 11 rules.
• Worked with different business groups to get new Veeva enhancement requirements.
• 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.
• 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.
• Worked throughout the SDLC, which included requirements, specifications, design, analysis and testing utilizing AGILE methodology.

Confidential, Bridgewater Township, NJ

Business Systems Analyst

Responsibilities:

• Involved in gatheringbusinessrequirements from the Subject matter experts (SMEs), conducting JAD sessions with stakeholders and documented them in a format that could be reviewed and understood by both businessand technical teams.
• Performed as abusinessand technicalanalystby 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 SharePoint document management system to share documents and to interact with client.
• Worked on Document Management, Service Definition, Workflow Management, Contact Management, Neutrals Management, Activity Management and Communications Management modules.
• Assisted in developing and Documenting timelines for Project Delivery, and managed Projects and Resources to successful completion
• Utilized MS Office products and Adobe Acrobat for technical writing. Utilized Collab net as the enterprise document management system for document capture and for version control
• Wrote BRD, FRD, use cases, test scenarios, test cases for testing the functional requirement.
• Validated the test data in DB2 tables on Mainframes and on Teradata using SQL queries.
• Involved in creating data mapping specifications from the Datawarehouse to SAS, Cognos and MicroStrategy datamarts.
• Worked along with the Project Manager and other BAs to develop various project plans to track down the time and progress of various projects using MS Project.
• Wrote PL/SQL statement and stored procedures in Oracle for extracting as well as writing data.
• Carried out extensive analysis of thebusinessrequirements and subsequently developed high level Use Cases.
• Created a Requirements Traceability Matrix (RTM) kept a track of product backlog, sprint backlog, and time estimates using agile tools like Jira.
• Prepared basic design diagrams including flow charts, data flow diagrams using MS Visio following the UML conventions.
• Converted functional specifications to technical specifications (design of mapping documents)
• Wrote Functional specifications for each of the ETL processes, working in close co-ordination withbusiness users and development leads.
• Reported the overall progress periodically to the Project Management andbusinessstakeholders.
• Maintained Requirements, Traceability Matrices and Attribute matrices using Rational Requisite Pro.
• Worked on Documentum for Version Controlling, to maintain up to date changes in the Documents.
• Worked extensively with the QA team for designing Test Plan and Test Cases for the User Acceptance Testing
• Managed the planning and requirements phase for the implementation of a Laboratory Information Management System (LIMS)
• 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).
• Involved in Analyzing and successfully completed the full product development life cycle of a high visibility, high throughput screening Laboratory Information Management System (LIMS).
• Utilized corporation developed Agile SDLC methodology. Used ScrumWork 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.
• Created 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.
• Conducted User Acceptance Testing (UAT), gathered and documented User Manuals andBusinessRules.

Confidential, Ridgefield, CT

Business Systems Analyst

Responsibilities:

• Interfaced with the client as part of the Requirements Engineering team to finalize the project scope.
• Conducted user interviews, gathered Requirements, analyzed the Requirements and managed changes using Rational Suite.
• Managed the project documentation using the Confluence document management system during the entire project cycle.
• Conducted JAD sessions with business users and Subject matter expert and stakeholders to define project scope, to identify the business workflows & task analysis and determine whether any current or proposed systems are impacted by the new development efforts.
• Acted as a liaison between IT teams and business partners to drive results and communicate opportunities, issues and risks formarketaccess, pricing and affordability.
• Managed Electronic Document Management System (EDMS) for automating R&D and Regulatory document repositories for submissions to the FDA.
• Participated in Requirement Gathering sessions for the IRMS (IntegratedRevenueManagementSystem)
• Maintained up-to-date knowledge of EHR software by attending lectures on health information technology
• Worked on Documentum for Version Controlling, to maintain up to date changes in the Documents.
• Worked with Documentum Enterprise content management (EDMS) using pharmaceutical GxP standards to capture, store, preserve and deliver content and documents related to organizational processes with Every Document Now Available (EDNA).
• Well-versed in documentation of Business Requirements Documentation (BRD), Functional Specifications Documentation (FSD), Current-State and Future-State Process Models, Performance Indicators.
• Conducted interviews with end-users to collect requirement andbusinessprocess information.
• Assisted in developing business process models in RUP to document existing and future business processes
• Created Process Flow diagrams, Use Case Diagrams, Class Diagrams and Interaction Diagrams using Microsoft Visio and Rational Rose.
• Managed and prioritized user stories using JIRA. Worked with the development team to identify blockers and provide resolution.
• Administration of Clinical R&D software including Oracle clinical, Clinapps PMD, Forecasting and sales and marketing software Spotfire and Cognos
• Involved in mentoring specific projects in application of the new SDLC based on the Agile Unified Process, especially from the project management, requirements.
• Identified internal and external system requirements, design and configuration set-up, also created User Documentation and conducted training classes.
• Assisted in developing Use Cases, Activity Diagrams, Sequence Diagrams, and OOD using UML.
• Assisted with user testing of systems, developing and maintaining quality procedures, and ensuring that appropriate documentation is in place.
• Used SQL to test various reports and ETL load jobs in development, QA and production environment
• Performed User Acceptance testing & End to End testing in interaction with Offshore QA/Dev teams for various system releases & pushed them to production.
• 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
• Responsible for writing the Test Cases and Test Scenarios based on the Functional Specification and technical Specification and documented in Mercury Quality Center.

Confidential, Wilmington, DE

Business Analyst

Responsibilities:

• Involved in conducting brainstorming sessions with executive sponsors, project champion and stakeholders to document problems with existingCTMSand potential solutions.
• Involved in development of Clinical Trial Management System (CTMS) integrated with EMR and customized to suit protocols following CDISC, GCP and other FDA standards.
• Involved in writing the Validation Assessment for the management to understand the importance of validation of core business functionality.
• Gathered the User Requirements from the Business Users and the Business Sponsor.
• Create customized dashboards for teams in Jira.
• Assisted and written System Requirements Documents SRD, including Functional and Non-Functional requirements.
• Assisted in developing the Functional Specifications based on the Business User Requirements along with the Lead Developer.
• Participated in reviewing companywide policies and QA procedures.
• Actively participated in conducting interviews, JAD sessions, requirements workshops and brainstorming sessions for eliciting business requirements
• Involved in creating UML-based feasibility studies and Use Case Models to communicate those ideas to the developers.
• Followed the UML based methods using Microsoft Visio to create: Use Cases Diagrams, Activity Diagrams, and Sequence Diagrams.
• Created the Test Plan for Protocol Execution and conducted Tester Training for the Test Script Execution.
• Executed and reviewed scripts for the formal validation process with implementation of cGMP.
• Maintained the Requirements Traceability Matrix (RTM).