SUMMARY:

• Qualified professional with over 10+ years of extensive experience working with the technical staff to implement management and staff's business requirements into the software application in Pharmaceutical Industry.
• Professional experience in with Business Analysis, Systems Analysis, Validation, Requirements Engineering, team leading and Project Management background in various industries such as Pharmaceutical Industry (Clinical, Supply Chain, Point of Sale (POS) and Pharmaceutical).
• Proficiency in validation protocols, technical writing, computer system/equipment validation, 21 CFR part 11, 58, 210, 211 and 820 compliance and Quality Assurance in FDA regulated environments.
• Highly motivated team player with excellent communication, presentation and interpersonal skills, always willing to work in challenging and cross - platform environment.
• Working knowledge of implementing software development projects using methodologies such as Waterfall, Rational Unified Process, Agile/Scrum.
• Utilized corporation developed Agile SDLC methodology. Used Scrum Work Pro and Microsoft Office software to perform required job functions.
• Experience with web application development, and SAS based clinical trials applications.
• 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.
• Highly proficient in working with users to gather requirements, analyze them and subsequently use the Rational project and design tools to model the requirements.
• In-depth knowledge of creating use cases, functional design specifications, activity diagrams, logical, component and deployment views to extract business process flow.
• Used Query Analyzer, Execution Plan to optimize SQL Queries.
• Extensively used rational tools for UML, tracking and reporting and applied the Rational Unified Process in all areas of a software development life cycle.
• Extensive scripting & reporting experience using VBA, MS Access & Excel Macros.
• Interviewed SMEs and Stakeholders to get a better understanding of client business processes and gather business requirements.
• Conducted JAD sessions, created Use Cases, work flows, screen shots and Power Point presentations for the Web Applications.
• Worked on modules in Veeva CRM.
• Well-versed in Electronic Data Capture (EDC) forms and programs such as Inform and Metidata.
• Experienced in Veeva IRep administration. Provided support and handled Veeva IRep applications to users.
• Maintained applications such as Veeva Vault.
• Have exposure to reading and manipulating programming languages such as LIMS Basic, C/C++, SQL, PL/SQL etc.
• In depth knowledge of SDLC and implementation of the Rational Unified Process (RUP) in all four phases of a project: Inception, Elaboration, Construction and Transition.
• Utilized a fusion of industry knowledge and technical programming to provide executive management the development and implementation of interactive business tools, and strategic analysis, vital for use in mission-critical decision-making.
• Conducted requirement gathering sessions, feasibility studies and Impact Analysis and organizing the software requirements in a structured way using Rational RequisitePro to track development.
• Interacted regularly with the development team, creative services, database designer, system administrator and the higher management to meet the deadlines of Project milestones.
• Worked in close co-ordination with the testing team in developing test plan and test cases from functional and business requirements.
• Created complex and reusable Macros and extensively used existing macros and developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation. Tested and debugged existing macros.
• Performed UAT and exposure to User Certification Testing (UCT) and Operational Readiness Testing (ORT).
• Expertise in understanding and supporting the client with Project Planning, Project Definition, Requirements Definition, Analysis, Design, Testing, System documentation and user training.
• Excellent experience in the areas of Design, Analysis and Development of Software Applications using Access and Excel VBA.
• Good knowledge of Workflows and Content Management Tools.
• Experience in Change Management Process (Identify, Analyze, Evaluate, Plan, Implement, Review and Close).
• Excellent skills in Project and Performance Management to support Strategic Planning, Goal Setting, Strengthen Accountability, Enhance Decision Making, and Improve Customer Service.
• Experience in implementing Microsoft Office SharePoint.

TECHNICAL SKILLS:

Programming Languages: C, C++, HTML, XML, SQL,PLSQL,JAVA,J2EE.

Data Base: MS Access, Oracle (SQL Series), DB2.

Reporting Tools: Crystal Reports.

Operating Systems: Windows, Apple McIntosh, Linux.

Software: MS Office Suite(Word, Excel, Access, PowerPoint & Outlook), MS Visio, Rational Rose, Rational Requisite Pro, Adobe Acrobat, MS Office FrontPage, Lotus Notes.

Computer System Validation: 21 CFR Part 11, 210/211, 50, 56, 58, 312, 314, cGXP (cGMP, GCP, GLP, GDP), GAMP 4, VMP, Validation Protocols (IQ, OQ, PQ), SOPs, RTM, SQL*LIMS, LabWare LIMS and Web LIMS, AERS, VSR, Audit Trials.

Processes/Technologies: Rational Unified Process (RUP), Waterfall, UML & Microsoft Office SharePoint.

Business Tools: Veeva CRM, Veeva Vault, Salesforce.com, Siebel, HP Quality Center.

PROFESSIONAL EXPERIENCE:

Confidential, Groton, CT

Clinical Project Manager/ Sr.Business Analyst

• Handled various activities of the project like information gathering from business, analyzing the information gathered, documenting the functional or business requirements.
• Held kick-off meeting to assemble project teams, assigned tasks, and delegated responsibilities, identified resources and reviewed detailed timelines, to ensure timely completion of assigned studies.
• Prepared weekly reports for upper management, regarding status of projects.
• Identified and effectively utilize necessary resources and skill sets required to advance successful and sustainable project
• Involved in preparing documentation for all aspects of the computer system validation lifecycle, in accordance with FDA regulations, particularly 21 CFR Part 11 including Installation Qualification (IQ) Specification, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification.
• Analyzed client’s business requirements and processes through document analysis, interviews, and workshops.
• Worked as an Interface between users and the technical teams involved in the application development for the better understanding of Business and IT processes.
• Performed regulatory and risk assessment of the computer systems.
• Critically reviewed and provided support for validation sections of regulatory submissions.
• Compiled project data, analyzes it, and prepares meaningful reports to be presented to senior management for decision making.
• Followed Contract research organization guidelines i.e. medical device industries in the form of research services outsourced on a contract basis.
• Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process.
• Actively participating in eCRF harmonization initiative, based on CDISC standards, across multiple diagnostic business areas within Roche.
• Communicated information about creating CDISC-compliant datasets.
• Provided clinical-study and clinical-trial support for drugs and/or medical devices through CROs Contract research organization specifically.
• Confirmed and verified data in the RIM software application according to established procedures. Performed assigned data entry to populate RIM software according to established procedures.
• Authored functional requirements in HP ALM tool and maintain Requirement Traceability Matrix.
• Developed and analyzed test plans and test scripts to check functionalities of application of 21 CFR Part 11 compliance and FDA regulations, GAMP 4&5, cGXPs (cGMP, cGLP, cGDP).
• Collaborated with Regulatory Submissions Management on a global level to revamp SharePoint site.
• Communicated client’s requirements to development team and testing team.
• Implemented, configured, and customized JIRA issue tracking software with Agile plugin across all company functions and acted as JIRA administrator.
• Created highly custom JIRA workflows, field configuration schemes, permissions schemes, screen schemes, security schemes, JQL queries, etc.
• Evaluated third party JIRA plugins to achieve results not included in standard implementation.
• Responsible for inputting data to sponsor specific for active and long-term follow-up using study specific web portals (i.e. Inform Oracle and Metidata).
• Co-ordinated with the team off-shore and make sure the work flow is in good pace.
• Established documentation for Agile methodology for implementation with a very water-fall-centric development team.
• Prioritized outstanding defects and systems problems, ensuring accuracy and deadlines were met.
• Communicated and managed relationships with functional and cross-functional team members to promote understanding,
• Developed and used metrics to measure progress and efficiency of team and met project goals, timelines and deliverables.
• Established track record in innovative problem solving through multiple academic endeavors as well as significant involvement in medical device ideation and execution.
• Interacted with the developers on resolving the reported bugs and various technical issues.
• Performed Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data.
• Used an iterative agile methodology was able to work side-by-side with the customer and the developers to create the technical developments throughout a series of rapid iteration deliverable.
• Incorporated Rational Unified Process (RUP) to create Requirement Document Specifications using Visible Analyst.
• Performed extensive data modelling to differentiate between the OLTP and Data Warehouse data models.
• Provided feedback to Veeva Product team on new capabilities such as Co-Browse and Targeting.
• Involved in Clinical Data analysis, Pharma Data reporting and Analysis.
• Wrote SQL Queries in Toad to sort data and analyze the large set of data during project life cycle.
• Involved in User Acceptance Testing, Smoke Testing, Regression Testing, Performance Testing and Functional Testing.
• Involved in writing efficient and effective Test Scripts and their review.
• Gathered integration requirements and source data.
• Performed data mapping from source to target systems.
• Worked across multiple functional projects to understand data usage and implications for data migration.
• Involved in planning and managing the data migration process.
• Worked with Subject Matter Experts and project team to identify, define, collate, document and communicate the data migration requirements.
• Developed information cycle diagrams, data flow diagrams in MS Visio.
• Wrote data mapping documents, data transformation rules and maintain data migration and interface requirements documents.
• Updated requirement documents as per business user feedback and changes.

Environment: MS Office (Word, Excel, PowerPoint), MS Visio, Rational, MS Project, SAS, SQL, Agile, JIRA, ASP, Visual Basic, Oracle, C++, WinRunner, LoadRunner, Test Director, Windows, SQL, PLSQL, Oracle, JAVA,J2EE,OBIEE,Clinical Lab Database, Windows, UNIX.

Confidential,St Louis, MO

Sr.Business Analyst

• Gathered analyzed, documented business and technical requirements from both formal and informal sessions and validate the needs of the business stakeholders.
• Conducted user interviews and documented business and functional requirements.
• Ensured accuracy of coding, which includes selecting appropriate event terms in MedDRA and worked closely with the coding department.
• Utilized medical terminology, MedDRA coding terms and obtained detailed information in prevention of quality assurance discrepancies.
• Coding relevant medical terminology, composed descriptive narrative and generated advanced condition queries.
• Cooperated with manager and individual publishers to complete all regulatory submissions effectively and efficiently
• Developed IQ/OQ/PQ test plans, traceability matrices, deviation forms and validation summary reports (VSR).
• Developed and executed IQ/OQ/PQ test plans and test scripts.
• Worked with SAS, Oracle, Metidata and other databases in reporting, data import/export, protocol evaluation, monitoring and reporting, data analysis and comparison for query resolution and building of data management plans.
• Performed Requirement Analysis and developed Use Cases, Activity Diagrams using Rational Rose.
• Ensured compliance with 21 CFR part 11 and GxP guidelines.
• Developed Validation Plan coordinating with the IT team to minimize the risks of data loss and verifying data integrity
• Documentation was created in accordance with the 21 CFR Part 11 regulations for the entire validation process
• Involved in creating business processes and modeling diagrams using Rational Unified Process (RUP).
• Created use case scenarios and documented work flow and business process using Rational Rose.
• Worked with different business groups to get new Veeva enhancement requirements.
• Responsible for ensuring delivers on all regulatory submission milestones and maintains compliance with applicable regulatory obligations.
• 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.
• Worked advanced Jira workflows based on user requirements.
• Coordinated with Veeva and Salesforce for any issues in current platform and new releases.
• Performed smoke testing during new product version release from Salesforce/Veeva.
• Used Toad Data Point for Data integration and report automation.
• Established collaborative partnership with key stakeholders to assess and recommend optimal business and technical solutions associated with medical devices
• Developed and worked on the PLSQL programs for the forms as required by the applications.
• Wrote Test Cases and performed User Acceptance Testing, documented the in detail defects using the Defect Tracking report.
• Created use cases to determine requirements of the proposed LIMS solution.
• Used Test Case distribution and development reports to track the progress of test case planning, implementation and execution results.
• Documented requirements, associated change requests with requirements and connected requirements with Use cases.
• Wrote test cases and test scripts for the User Acceptance Testing.
• Conducted requirements gathering and developed strategy maps and roadmaps for delivering Data Analytics and BI Reporting via TIBCO Spotfire in-memory technology.
• Designed and developed TIBCO Spotfire software applications and server-based TIBCO Spotfire dashboards from scratch to support BI initiatives.
• Converted multiple reports from Excel, Tableau and BO to TIBCO Spotfire.
• Identified/documented data sources and transformation rules required populating and maintaining data warehouse content.
• Maintained benchmark controls to policies, company standards and contracts, performed vendor sourcing, pricing and contract negotiation, performed procurement, ensured compliance with service/joint interest contracts.
• Used Rational Clear case for version control.
• Involved with all the phases of Software Development Life Cycle (SDLC) methodologies throughout the project life cycle.
• Served as conduit for managing system requirements between the business and the software development team.
• Used Rational clear quest for defect management.

Environment: Windows XP Professional, Oracle, Agile, JIRA, SQL, MS Access, MS Excel, JAVA, J2EE, RUP, Oracle Forms, Oracle Reports, SQL, PLSQL, TOAD, SQL*Loader, SQL Plus, UNIX, Oracle, UML, Rational Rose, Requisite Pro, Clear Case, Rational Clear Quest, MS Office suite, MS Visio.

Confidential,Cambridge, MA

Business Analyst

• 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.
• Data mapping, logical data modeling, created class diagrams and ER diagrams and used SQL queries to filter data within the Oracle database.
• Performed Gap Analysis of the processes to identify and validate requirements.
• Worked closely with developers in the development and implementation of the specified modules in LIMS.
• Identified/documented data sources and transformation rules required populating and maintaining data warehouse content.
• Assigned short-term tasks/projects to junior analyst in effort to improve data integrity in our RIM software.
• Studied design and implementation global library and study specific setup for clinical trials applications.
• 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.
• Validated computer systems and various in-house software applications according to FDA and cGxP regulations.
• Developed and implemented a complete software validation life cycle using V-model for installation of various in-house software applications.
• Drafted URS, Analyzed and prepared IQ/OQ/PQ Test Scripts to check if it has covered the functionalities, which need to be in compliance with 21 CFR Part11 rules set by FDA.
• Prepared detailed user friendly compliance reports of the documentation for the entire project in agreement to FDA standards.
• Applied UML notations and methodology in developing models that accurately represent the business process and workflows and clearly communicate them to the stakeholders.
• Facilitated JAD sessions involving the management, development and user teams for clarifying requirements and facilitating better communication.
• Actively involved in validating the requirements and applying the Agile framework throughout the SDLC.
• Created Process Flow diagrams, Use Case Diagrams, Class Diagrams and Interaction Diagrams using Microsoft Visio and Rational Rose.
• Forecasted impact of direct market campaigns for acquiring, developing and retaining customers using SAS.
• Involved in story creation and pair testing as part of agile development process
• Developed and maintained SAS Web Reports for sales data based on the requirement.
• Generated Excel VBA Performance/Risk Exposure reports for Portfolio/Senior Managers.
• Wrote PL/SQL statement and stored procedures in Oracle for extracting as well as writing data.
• 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.
• Maintained proper communication with the developers ensuring that the modifications and requirements were addressed and also monitored these revisions.
• Designed Functional Specification Documents for the reports.
• Coordinate and prioritized outstanding defects and enhancement/system requests based on business requirements, allowing sufficient time frame to ensure accuracy and consider deadlines
• Review the Test Plan developed by the testing team for testing the application.
• Deep understanding of all the phases of Software Development Life Cycle (SDLC) methodologies throughout the project life cycle.
• Involved in performing version control and defect tracking activities using Rational ClearCase and Rational ClearQuest.

Environment: Oracle, SQLite, MySQL, Sybase, DB2, Agile, SQL Server Oracle /PHP/TOAD, MySQL/PHP/TOAD, DB2, Sybase. ACCESSBusiness Modeling and Data Modeling Rational Rose, JAVA,J2EE, Rational Requisite Pro, MS Visio, Clear Case, Clear Quest.

Confidential,San Diego, CA

Business Analyst/Systems Analyst

• Responsible for defining the scope and implementing business rules of the project, gathering business requirements and documentation.
• Responsible for writing Functional Requirement Specifications (FRS) and User Requirement Specification (URS).
• Analyzed Business Requirements and segregated them into high level and low level Use Cases, Activity Diagrams / State Chart Diagrams using Rational Rose according to UML methodology thus defining the Data Process Models.
• Understand the As Is system and develop the To Be system concept and also prepare the System Process Maps.
• Resolved production issues such as presentation and key message visibility on Veeva IRep, FTP server access, asset migration from sandbox to production environment etc.
• Prepared an analysis report based on the COTS evaluation.
• Consolidated the analysis of multiple business lines after the COTS evaluation.
• Gathered legacy system requirements by shadowing Customer Service Representatives (CSRs), Customer Relationship Representatives (CRRs), preparing questionnaires, to identify limitations in the current system and GAPS in the proposed system.
• Worked closely with Spotfire Technical consultants providing them solutions to various service requests.
• Performed extensive Requirement Analysis including data analysis and gap analysis.
• Successfully conducted JAD sessions, which helped synchronize the different stakeholders on their objectives and helped the developers to have a clear-cut picture of the project.
• Facilitated several Meetings involving the Business and Technical teams in agile environment
• Implemented Agile Framework throughout the software Development Life Cycle (SDLC).
• Conducted presentations of the Q/A test results with analysis to the stakeholders and users and documented modifications and requirements.
• Converted Various Excel, Tableau and BO Reports to Spotfire.
• Maintained integrity of data in Veeva CRM to ensure promotional items are up to date.
• Conducted Unit testing of the reports developed in Spotfire Professional.
• Worked on Veeva CRM and Vault implementation
• Worked on developing training program, user guide for Spotfire Professional and Spotfire web player in terms of best developing and design practices.
• Used SAS Macros, PROC SQL to extract, sort; match test accounts and ODS to HTML, PDF and RTF.
• Coordinating and Developing QA activities.
• Created Process Flow diagrams, Use Case Diagrams, Class Diagrams and Interaction Diagrams using Microsoft Visio and Rational Rose.
• Wrote Test Cases and performed User Acceptance Testing, documented the in detail defects using the Defect Tracking report.
• Used Test Case distribution and development reports to track the progress of test case planning, implementation and execution results.
• Wrote PL/SQL statement and stored procedures in Oracle for extracting as well as writing data.
• 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
• Maintained proper communication with the developers ensuring that the modifications and requirements were addressed and also monitored these revisions.
• Involved in compatibility testing with other software programs, hardware, Operating systems and network environments.

Environment: Requisite Pro, Rational Rose, PL/SQL, HTML, MS Office, MS Visio, EDI, UML, Oracle, Oracle Forms,Oracle Reports, SQL, PLSQL, TOAD, SQL Loader, SQL Plus, UNIX.

Confidential

Business Analyst

• Managed and led a team of 12 members which includes Business Analyst & QAs under Groups Information security.
• Understood & created current process & proposed process diagrams
• Performed Requirement Analysis, developed Use Cases & Activity Diagrams.
• Prepared BRD, FRD (using Process Flow, Use Cases, and Wireframes), and RTM (Requirement Traceability Matrix)
• Performed UAT to check if requirements are implemented as expected.
• Ensured the application follows the Global Information Security policy.
• Defined & Governed the Key Control Indicator and Key Risk Indicator for processes as part of Audit remediation program
• Defined and implemented monitoring of operations team framework globally (CH and KL Ops team), Created the process document and get approval
• Created Security Matrix Update process document and get approval
• Performed Root Cause Analysis (RCA) for escalated issues from Identity and Access management team.
• Registered Identified risk in Risk wise or Phoenix on the relevant team.
• Reported Identified gaps in the process to the process owners.
• Participated in Status review and reporting meetings.
• Worked on multiple projects in a high-stress environment under aggressive deadlines.
• Ensured cross-functional training for all QA activities to all QA team members.

Environment: Windows 7, MS Project, Waterfall, MS Office Suite, UML, MS Visio, Java, Oracle 10i.

Confidential

Business Analyst

• Created and analyzed performance reports and used the data to implement changes and updates that improve service and performance.
• Required to meet aggressive ad hoc deadlines and work on special projects. (Projects included major software upgrades for the service center and institution of an email channel for customer service.)
• Analyzed and documented Fact Sheets, Business Requirement Document (BRD), Functional Specification Documentation, and System Requirement Documentation.
• Conducted meetings to understand the workflow, their processes and assisted in GAP Analysis to derive requirements for existing systems enhancements.
• Worked closely with Team Managers and monitored phone calls and productivity of Representatives and HR analysts to ensure the effectiveness of service.
• Worked with a team of Operations Managers, Supervisors, and other HR Analysts to update standards and establish goals.
• Worked closely with the HR Service Center managers to ensure the effectiveness and quality of the service our personnel deliver.
• Converted raw images and layouts from a graphic designer into CSS/HTML themes.
• Coded Tested and debugged Java code and Servlets using Eclipse
• Designed and executed test plans, tracked defects and got them resolved to ensure that business requirements and functional specifications were tested and fulfilled.
• Developed POC using Silver light 4, XAML, Expression Blend, and C #
• Developed Data Access Components using LINQ using .NET4 C#, VS2010
• Design of ASP.NET Applications using MVC
• Supported the Training and Business Process Management departments as a Subject Matter Expert.
• Responsible for organizing customer feedback for the HR Director and other management positions on monthly basis.

Environment: MS Office Suite, MS Project, RUP, UML.NET4 C#, VS2010, MS Visio, Eclipse, SharePoint, CSS/HTML.