SUMMARY

• 7+ years of Industry experience as a Sr. Data Analyst with solid understanding of Business Intelligence, Data warehousing, Data Mapping, Data Validation, Data Integrity, Master Data Management (MDM), Reporting, Data Governance, Data Stewardship and Data Modeling.
• Experience as a Data Analyst in Pharmaceutical and Healthcare domain and experience as a passionate business, process, and qualitative analyst with expertise in understanding business problems.
• Extensive experience working QA and Validation capacity in sterile manufacturing, Biotechnology.
• Comprehensive knowledge of software development methodologies such as Waterfall, RAD, RUP and AGILE SCRUM.
• Experience in data extracting (ETL), MIS Reporting, data Conversion and manipulation, transformation, data cleansing and suppressions, data validation & error trapping, testing and loading large data sets into SAS from various applications/databases (Oracle, Teradata, DB2, SQL server, Access, spread sheet, text files) and environments (windows, UNIX, TSO/MVS Mainframe).
• Experience, providing statistical programming support for multiple clinical research projects in pharmaceutical, biotechnology and contract research organization (CRO) industries
• Strong knowledge of FDA QS 21 CFR 820, 211 for Pharmaceutical, Life Science and Health Care Industries and cGMP, GCP, GLP, CAPA, GRP, EMR, EHR & QMS.
• Worked heavily onClinical Trials using IVRto conduct global clinical trials and manage the large volumes of data generated.
• Experience in ETL tool using info Informatica (PowerCenter Designer, Repository Manager, workflow Manager, workflow Monitor).
• Experience in Clinical Data Managementand Clinical Trials Management.
• Strong knowledge in working on the ETL Informatica mappings and other ETL Processes (DataWarehouse)
• Experience in Reviewing of Standard Operating Procedures SOPs using Rational Requisite Pro.
• Good experience in Data Modeling with expertise in creating Star & Snow - Flake Schemas, FACT and Dimensions Tables, Physical and Logical Data Modeling using Erwin.
• In depth knowledge Rational Unified Process (RUP) methodology, Use Cases, Software Development Life Cycle (SDLC) processes, Object Oriented Analysis and Design (OOA/D).
• Expert in analysis, design, development and implementation of Business Intelligence (BI) solutions focused on streamlining data for operational, functional, and enterprise level reporting.
• Managed all aspects of the data warehouse such as data migration, validation, integration, cleansing, database/query optimization, stored procedures, functions, view, creating index,reporting. Extensive experience in all phases of RUP and SDLC processes
• Facilitated Change Management across entire process from Project conceptualization to Testing through Project Delivery, Software Development and Implementation Management in diverse Business and Technical Environments.
• Demonstrated ability to adapt into new environments, learn new skills and participate teams.
• Acquainted with SQL, Quality Center, Quick Test Pro, Win Runner and load Runner.
• Hard-core experience involving Business Process Re-Engineering, Software Re-Engineering using RUP methodology and ERP Systems Implementation and Continuous Improvement techniques.
• Directly managed multiple projects involving multiple team sizes. One of the key projects involved Clinical Trial using SCRUM development methodology handling highly sensitive data. Recommendations established new firm wide coding and testing standards.
• Have worked in Data Market Systems,BPMand SQL queries.
• Worked closely with various project stakeholders, SME’s & developers to understand and document business requirements, functional requirements and design specifications for new applications along with enhancements to the existing applications.
• Software Development Life Cycle (SDLC) experience including Requirements, Specifications Analysis/Design and Testing as per the Software Development Life Cycle.
• Responsible to Track, Document, Capture, Manage and Communicate the Requirements using Requirement Traceability Matrix (RTM) which helped in controlling numerous artifacts produced by the teams across the deliverables for a project
• Experience with System Life Cycle (SLC) and Medidata RAVE application.
• Strong experience in conducting User Acceptance Testing (UAT) and documentation of Test Cases. Expertise in designing and developing Test Plans and Test Scripts.
• Highly motivated team player with excellent Interpersonal and Customer Relational Skills, Proven Communication, Organizational, Analytical, Presentation Skills, and Leadership Qualities.

PROFESSIONAL EXPERIENCE

Confidential, Princeton, NJ

Sr. Data Analyst

Responsibilities:

• Collaborated with Clinical Research to accommodate to New Business Requirements.
• Assessed the current system documentation for the Clinical Research Collaborations CRC System and provide recommendations for consolidating and updating the existing system documentation.
• Prepared Test Plans for each release, written Test Cases and executed them as part of Functional Testing. Prepared Test Reports and Deliverables and submitted for version releases.
• Involved in end-to-end Veeva Implementation for the Bio-Pharma industry, R&I, Diabetes Care etc.
• Involved in validation of LabWare LIMS by developing, executing and documenting SOPs, Test Plans and Test Scripts.
• Implemented the project using the Waterfall Methodology to produce artifacts in the different phases of the Software Development Life Cycle (SDLC).
• Effectively participate in clinical research activities including design, consent, data gathering and data retrieval
• Regular interaction with the core developers helped us in fixing the defects in less time.
• Used SQLs to test various reports and ETL load jobs in development, QA and production.
• Played key role in defining test automation procedure and standards, creating Win Runner and QuickTest Professional scripts for all the modules, which reduced the regression cycle drastically and improved the testing efforts for daily builds.
• Played active role during daily scrum meeting and task planning as part of agile methodology
• Involved in providing Sales force automation solutions using the Veeva system suite of applications such as Veeva iRep, Veeva Vault, CLM (Closed Loop Marketing) etc.
• Act as client subject-matter expert for internal teams such as development and testing and on all elements of the requirements.
• Production support applications break fixes were immediately resolved as well as modifications/updates, MIS Reporting, ETL, Data conversion, manipulation and occasionally new applications were implemented using SAS/UNIX scripting, X Manager Reflections, Teradata, FUTRIX, Tableau.
• Developed use case documentation for system requirements, business process flows, and screen mockups using MS Visio.
• Involved in Data Modeling of both Logical Design and Physical design of data warehouse and data marts in Star Schema and Snow Flake Schema methodology.
• Developed and Documented Use Cases for the intended system.
• BusinessProcess Management (BPM), Use Case modelling using UML, Data Modelling, Project
• Involved in delivering EnterpriseDataGovernance,DataQuality, Metadata, and ETL Informatica solution
• Met project milestone dates for Technical Use Cases and Test Script completion dates for Phase releases.
• Performed Black Box testing and conducted Functionality and Regression testing on various phases of the Management software
• Extensively used Informatica Client tools like Informatica Repository Manager, Informatica Designer, Informatica Workflow Manager and Informatica Workflow Monitor.
• Interfaced with business users to verify business rules and communicated changes to ETL development team.
• Used Teradata utilities Fast Load, Multi Load, tpump to load data.
• Process Mapping; created work-stream, reporting, and UI process diagrams to analyze the current business state, identify problem areas and to help create the best possible user experience in the future.
• Worked on MasterDataManagement (MDM) for maintaining the customer information and also for the ETL rules to be applied.
• Created automated Load test scripts using Load Runner.
• Conducted technology comparison, tool/solution assessment and solution selection from several potential solutions, including SharePoint, Clinical Trial Management System CTMS and customized systems.
• Used SQL for querying and analysis purposes on various source tables and conditions applied and Wrote SQL joins, sub queries.
• Used SQL Server Reporting Services SSRS to schedule reports to be generated on predetermined time.
• Conducted GUI and functionality testing using QTP.
• Involved in designing and developing data management application on with central operational database.
• Provide IT quality compliance support to R&D and Medical Devices projects.
• Worked in identifying the efficient Design flow for migrating from SQL Server to Oracle Exadata Platform.
• Tested Inbound and Outbound Feeds of different format (XML, Pipe-Delimited, CSV)
• Conducted data driven testing using QTP to conduct backend testing
• Created Data profiling stored procedures using dynamic SQL as well as generating complex scripts to schedule various maintenance tasks.
• Involved in process modeling, conducted & Participated in Joint Application Development (JAD) sessions with System Users.
• Consultant at a medical device company on a GxP program documenting laboratory and production applications.
• Responsible for cost estimation and timelines for various Business Intelligence reports
• Used Test Director and Mercury Quality Center for updating the status of all the Test Cases & Test Scripts that are executed during testing process.
• Performed Load and Stress Testing using Load Runner.
• Automated confidence tests that run on new builds on regular basis.
• Involved in setting up different configuration environment for compatibility testing and manual testing.
• Upgraded the existing Test Scripts and created new scripts for client application to be able to work for new versions and patches, which improved product quality.
• Evaluated testing results for each potential release build using Test Director, 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 feed back to QA team & Manager.

Confidential, Plainsboro, NJ

Data Analyst

Responsibilities:

• Enter data from various sources into EDMS Electronic Document Management system
• Assuring that all validation documentation such as Process Validation and Software Validation are in compliance with GMP's
• Created relationships in Requirement Traceability Matrix linking Business Requirements to Functional requirements and Functional Requirements to Systems Requirements.
• Enhancement related to pl/sql and sql for Oracle Clinicals (oracle product used by client for clinical trials)
• Conducted Joint Application Development (JAD) sessions with IT groups. Identified the Key Changes, and participated in Stakeholder Management to communicate effectively with them
• Work independently with Veeva Vault pharmaceutical clients and Veeva configuration specialists to design and deploy customized document management system portals for marketing, legal, regulatory, medical, compliance, clinical, research and safety teams.
• Involved in Migrating the Informatica objects using Unix SVN from Dev to QA Repository.
• Analyzing the requirements and data availability as well as Capacity Planning then create programs using SAS, SAS/SQL in a WAP UNIX environment accessing Teradata/DB2 database as well as Oracle databases followed by testing, data regression, data manipulation and user acceptance.
• Worked on Data mapping, logical data modeling used SQL queries to filter data within the Oracle database tables
• Worked with OLAP tools such as ETL,Datawarehousing and Modeling, Used Informatica / SSIS to extract, transform &loaddatafrom SQL Server to Oracle databases.
• Developed and Documented timelines for Project Delivery, and managed Projects and Resources to successful completion.
• Assist in the co-ordination and management of various activities associated with clinical trial planning and initiation including clinical trial budget and agreement review, third-party vendors identification, and site/study feasibility assessment; among other responsibilities.
• The Agile-scrum SDLC was used and I participated in writing user stories to track requirements and used SharePoint to share and maintain the document versions.
• Involved in Data mapping specifications to create and execute detailed system test plans. The data mapping specifies what data will be extracted from an internal data warehouse, transformed and sent to an external entity.
• 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.
• Collaborate withdatamodelers,ETLdevelopers in the creating theDataFunctional Design documents.
• Involved in exhaustive documentation for technical phase of the project and training materials for all data management functions
• Extensively used both Star Schema and Snowflake schema methodologies in building and designing the logicaldatamodel in Dimensional Models.
• Researching, analyzing, projecting cost of inventory for projects, reconciling balances, process mapping, developing policies and procedures to improve tracking and issuing of Watershed material, preparing MS Excel, and MS Word Reports for Senior Management.
• Responsible for managing process of recycling and disposal of used material and obsolete.
• Interacted with users for verifying User Requirements, managing Change Control Process, updating existing Documentation
• Worked on Documentum for Version Controlling, to maintain up to date changes in the Documents.
• Used Data Loader for insert, update, upsert, and bulk import or export of data from Salesforce Objects. Used it to read, extract and load data from comma separated value (CSV) files.

Confidential, Bannockburn, IL

Data Analyst

Responsibilities:

• Analyzed and reviewed various low-level and high-level requirement documents such as Technical Requirement Documents (TRD), Use Cases, Design Documents (DD), Application Design Documents (ADD), and Process Flow Diagrams.
• Expertise in working with clinical trial data like demographic, AE, SAE, Lab, Vital Signs and CRF/e-CRF, other essential documents in clinical Research.
• Experience in Clinical Data Analysis in accordance with guidelines and providing Clinical Study Reports.
• Identify source systems, connectivity, tables, and fields, ensure data suitability for mapping.
• Designed data flow models, and performed functional decomposition analysis on various business processes.
• Responsible for business system analysis of customizing the BPS Risk Management product with involvement through the whole SDLC.
• Clinical research regulatory specific knowledge to maintain SOPs, ICH guidelines, SAE reporting and GCP auditing
• Understanding of Good Manufacturing Practices (GMP), regulatory, and IT quality system requirements.
• Conducted preparatory sessions, joint application development sessions and workshops with SMEs and Stakeholders to capture and analyze requirements
• Responsibilities included creating production as well as Adhoc reports using PC/SAS/SQL accessing DB2 as well as Oracle databases.
• Introduced Agile and RUP methodologies to reflect liquid nature of front-office improving time-to-market
• Responsible for requirement and design documentation review, test plans, identifying and reporting software anomalies and test results.
• Responsible for scheduling workflows, error checking, production support, maintenance and testing of ETL procedures using Informatica session logs.
• Performance tuning on sources, targets mappings and SQL (Optimization) tuning.
• Create internal and external reports using stored procedures from the Reporting Data Warehouse.
• Generating Data Models using Erwin and developed relational database system and involved in Logical modeling using the Dimensional Modeling techniques such as Star Schema and Snow Flake Schema.
• Tested ComplexETLMappings and Sessions based on business user requirements and business rules to loaddatafrom source flat files and RDBMS tables to target tables.
• Conducts coverage analysis of clinical research trial procedures to delineate standard of care and research procedures; reaches out to research site to assist in determining charge direction.
• Conducted process mapping and process pinch points during a Kaizen activity to reduce tool and manpower waste.
• Perform Gap Analysis of the processes to identify and validate requirements.
• Created test scripts for all the test cases in PL/SQL.
• Tested theETLprocess for both beforedatavalidation and afterdatavalidation process. Tested the messages published byETLtool anddataloaded into various databases
• DevelopedData Mapping, Data Governance, TransformationandCleansingrules for the Master Data Management Architecture involving OLTP, ODS and OLAP
• Prepared Test Plans for each release, written Test Cases and executed them as part of Functional Testing. Prepared Test Reports and Deliverables and submitted for version releases.
• Involved in interactions with the Subject Matter Expert, Project Manager, Developers, and the end-users to gather key issues involved in the project and propose the new solutions.
• Used the guidelines of the Rational Unified Process (RUP) to strategize the Implementation of Rational Unified Process effort in different iterations and phases of the project.
• Developed detailed use cases using Rational Software.
• Kept a close watch on the changes involving constant communication with the developers.
• Supported the assigned project manager with creating detailed project plans; assisted in developing, scheduling and tracking project timelines.
• Worked with the UAT team to validate that the developed application will meet the business requirements.

Confidential, Dublin, OH

Data Analyst

Responsibilities:

• Prepared Test Plans for each release, written Test Cases and executed them as part of Functional Testing. Prepared Test Reports and Deliverables and submitted for version releases.
• Worked for a project to customize and integrate aBusinessProcess Management (BPM) solution.
• Regular interaction with the core developers helped us in fixing the defects in less time.
• Played key role in defining test automation procedure and standards, creating Win Runner and QuickTest Professional scripts for all the modules, which reduced the regression cycle drastically and improved the testing efforts for daily builds.
• Mapping of data for the early-stage development clinical trials study through an application named Trial Setup.
• Worked with multiple project teams of technical professionals through all phases of the SDLC using technologies including Oracle, Erwin,DataStage,DataWarehousing,Websphereand Cognos.
• Worked closely with project managers in reviewing requirements from end users and developed report layouts using SAS EG, SQL.
• Experience implementing Collibra to automate data management processes.
• Extensively used Star Schema methodologies in building and designing the logicaldatamodel into Dimensional Models.
• Responsible for coding the complex clientPBMplan designs within the adjudication support system.
• Performed Black Box testing and conducted Functionality and Regression testing on various phases of the Management software
• Experienced working in the area data management including Data Modeling, Metadata, Data Analysis, Data Integrity, Data Mapping and Data Dictionaries.
• Involved in projects such as: the adoption of JIRA from business process standardization to tailoring of JIRA to not only meet the needs of project teams but also to increase the efficiency of communication
• Wrote SQL Queries in MS Access to sort data and analyze the large set of data during project life cycle.
• Created automated Load test scripts using Load Runner.
• Conducted GUI and functionality testing using QTP.
• Created the design and technical specifications for theETL processof the project.
• UsedInformaticaas an ETL tool to create source/target definitions, mappings and sessions to extract, transform and load data into staging tables from various sources.
• Responsible for mapping and transforming existing feeds into the new data structures and standards utilizingRouter, Lookups Using Connected, Unconnected, Expression, Aggregator, Update strategy & stored procedure transformation.
• Worked on Informatica Power Center tool -Source Analyzer, Data Warehousing Designer, Mapping Designer & Mapplets, and Transformations.
• Conducted JAD sessions with SMEs and other stakeholders for open and pending issues
• Created and reviewed the conceptual model forthe EDW (Enterprise Data Warehouse) with business users.
• Tested Inbound and Outbound Feeds of different format (XML, Pipe-Delimited, CSV)
• Conducted data driven testing using QTP to conduct backend testing
• Developing and executing project validation deliverables, such as; Validation Plans, Migrations Plans, IQ/OQ/CQ, System, Integration and UAT test scripts.
• Used SDLC (SystemDevelopment life Cycle) methodology like Agile and Scrum.
• Responsible for cost estimation and timelines for various Business Intelligence reports
• Used Test Director and Mercury Quality Center for updating the status of all the Test Cases & Test Scripts that are executed during testing process.
• Involved in setting up different configuration environment for compatibility testing and manual testing.
• Upgraded the existing Test Scripts and created new scripts for client application to be able to work for new versions and patches, which improved product quality.
• Evaluated testing results for each potential release build using Test Director, 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 feed back to QA team & Manager.

Confidential, Atlanta GA

Data Analyst

Responsibilities:

• Quality Engineer in the IT Quality organization responsible for project management, process development, technical writing, process mapping and process improvement.
• Used the guidelines and artifacts of the Rational Unified Process (RUP) to strategize the Implementation of RUP effort in different iterations and phases of the Software Development Life Cycle.
• Worked as an Interface between the Users and the different teams involved in the application development for the better understanding of the Business and IT Processes.
• Attending project team meetings, worked with bio-statisticians, data management team, and clinical research managers as appropriate
• Utilized corporation developed Agile SDLC methodology. Used Scrum Work Pro and Microsoft Office software to perform required job functions.
• Followed PPD's System Life-Cycle (SLC) and Computer System Validation (CSV) procedures, as appropriate
• Followed the UML based methods using Microsoft Visio to create: Use Cases Diagrams, Activity Diagrams, State Chart Diagrams, Sequence Diagrams and Collaboration Diagrams.
• Responsible for designing, developing, testing, documenting and delivering technology solutions for Microsoft Dynamics ERP, Management Reporter, Crystal Reports, and SQL Server including customizations and alterations to existing applications.
• Created the design and technical specifications for theETL processof the project.
• UsedInformaticaas an ETL tool to create source/target definitions, mappings and sessions to extract, transform and load data into staging tables from various sources.
• Promoted, Implemented and Tested Informatica objects from Development to UAT to Production environments.
• Involved in preparing Test Plan and Operational Qualification Protocol (OQ). Developed IQ, OQ, PQ Test Scripts and Scenarios based on FRS and System Design Document. Executed the developed and existing scripts for both dry run and formal testing.
• Environmental monitoring (mapping) for GMP regulatory compliance (stability chambers, cold storage spaces, controlled substance vaults, clean room Grade A and B sterile manufacturing)
• Extensive use Enterprise Document Management System (EDMS) such as Livelink and Ms SharePoint
• Prepared Logical Data Models that contain set of Entity Relationship Diagrams and Data Flow Diagrams and supporting documents and descriptions of the Relationships between the data elements to analyze and document the Business Data Requirements.
• Worked extensively with the QA team for designing Test Plan and Test Cases for the User Acceptance Testing.