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Click here or scroll down to respond to this candidateEmail: EMAIL AVAILABLEPhone: PHONE NUMBER AVAILABLECandidate's Name
SUMMARY:A Certified Scrum Product Owner with over 9 years of industry experience as a Senior Business Analyst contributing to Requirements Documentation, Need Assessments, Data Analysis and the design of high-quality business solutions. Strong knowledge of all the phases of Software Development Life Cycle (SDLC) and methodologies such as Agile, Scrum and Prototype models.Expertise in facilitating JAD sessions with business users and development team to drive out detailed business requirements using various techniques from BABOK (Business Analyst book of knowledge). Also conducted one on one interviews, survey/questionnaires, brainstorming sessions, document analysis for requirement elicitation.Proficient in conducting GAP analysis of AS-IS and TO-BE systems, SWOT analysis, Impact analysis, Feasibility analysis, Cost-benefit analysis, Cause & Effect analysis and Risk analysis.Experience in creating various project artifacts such as Business Requirements Document (BRD), Functional Specifications Document (FSD/FRD) and Systems/Technical Requirements Specifications (SRS/TRS), Use Case documentation.Expertise in gathering SMART (Specific, Measurable, Attainable, Realistic, Timely) requirements and transforming them into functional specifications focusing on workflow/user interface analysis and design.Trained in Good Clinical Practices GCP for work with the Clinical Trials area and GDP for documentation.Familiar with IT systems and technologies commonly used in healthcare, including EHR/EMR systems, health data standards (e.g., HL7) and healthcare application integration.Understand eCommerce business cross B2C, B2B, O2O, Social network, internet trend, Digital related commerce model.Proficient in UML by creating Use-Case diagrams, Sequence diagrams, Activity diagrams, RACI diagrams and Class diagrams using MS Visio, Rational Rose as well as creating mock-up screens and prototype screens.Good knowledge of database relationships and concepts, worked on RDBMS like MySQL and MS SQL server.Experience in creating specifications and developing Conceptual, Logical and Physical ER diagrams.Strong knowledge in software testing life cycle, reviewed and approved test plans and test cases, use of testing tools and Defect tracking mechanism and coordinate User Acceptance Test activities.Experienced in project management tools such as Microsoft Project, HP Application Lifecycle Management (HP ALM), JIRA, Rally and Team Foundation Server (TFS).Experience with Rational Suite products Rational ClearQuest, Rational Rose Rational Requisite Pro.Extensively worked with Microsoft suite of products such as MS office, MS Visio, MS Excel, MS Project.Well versed with agile scrum processes like facilitation of scrum ceremonies and managing requirements churn.Knowledge and experience with widely successful agile techniques: User Stories, Velocity, Story Points, Product/Sprint Backlog, Burndown/Burnup Charts, Test Driven Development, Pair Programming.Excellent in analytical, problem solving, documentation and leadership skills.TECHNICALUML ToolsRational Requisite Pro, Rational Team Concert, MS Visio, Rational RoseProject Management ToolsRally, Atlassian JIRA, Confluence, MS SharePoint, MIROData ModelingPhysical Modeling, Logical Modeling, Relational Modeling, Dimensional Modeling (Star Schema, Snow-Flake, Fact, Dimensions), Entities, Attributes, Cardinality, ER Diagrams.PlatformsWindow, Microsoft, iOS, Linux, UnixDatabasesOracle 10g/11i, SQL Server 2012, DB2, Sybase, MS AccessMiscellaneousCANVAS Web Builder, Veeva Salesforce, Veeva CRM, ERP, SmartDraw, Bizagi, Visual Studio, VMware, Virtualization, Ra9onal DOORs, CaliberRM, StarTeam and ETL, Adobe AnalyticsEXPERIENCEPfizer July 2021 - April 2024 Sr.Business AnalystRoles and Responsibilities:Conducted Fit Gap Analysis for a web based software medical device (PredicTTR application), identifying gaps between existing functionality and business requirement, and documenting them for further action.Worked closely with the business on end-to-end requirement reviews, ensuring through understanding and alignment with project objectives.Verified ALM test scripts for identifying the gaps.Coordinated with the Digital Risk Management team on regenerating/dispositioning of the CRS requirements in IPRM.Collaborated closely with the Product Owner for requirements gathering.Maintained a healthy backlog and ensured alignment with Definition of Ready (DOR) and Definition of Done (DOD) criteria.Refined user stories and acceptance criteria in JIRA tickets.Liaised with the Design Agency to secure MLR (Medical, Legal, Regulatory) approval post PO's design approval.Worked on fine-tuning and documenting requirements in the form of functional requirements, non-functional requirements, use case diagrams, use case narratives and user stories.Coordinated with Agile Project Manager and Product Owner and delivered Scope definition for planning and estimation, Backlog Analysis to estimate and prioritize feature delivery.Participated in project planning, project capacity planning, requirements elicitations (workshop facilitator, documentation, verification, and sign-off), requirements analysis, risk identification and mitigation planning, development of user acceptance test conditions and test strategy, issues and defects management.Wore multiple hats as a Product Owner and Scrum Master.Provided progress updates and prioritized the backlog for the ART Leadership Team.Played a pivotal role in Program Increment (PI) planning.Coordinated with Brand teams for uploading their brand palettes to the web builderConducted User Acceptance Testing (UAT) for all developed features.Contributed to the migration of documents to Adobe Franklin.Demonstrated proficiency in testing analytics using Omnibug and generating Adobe reports.Managed the end-to-end process of Brand kits creation to upload them to the CANVAS web builder.Conducted sessions with business SMEs for high-level requirements gathering.Collaborated with the Analytics team to analyze and bridge gaps for the Solution Design Document.Created Documentations for all the developed featuresCaris Life Sciences - Irving, TX Oct 2019 June 2021 Sr. Business AnalystResponsibilitIes:Evaluated company business processes across sales organizations prioritizing issues and recommendations for the merging of Ortho marketing business groups.Developed and maintained sales reporting using MS Excel queries, SQL and MS Access.Produce performance reports and implement changes for improved reporting.Created validation transfer plans for four separate assays while collaborating with Sales, Marketing, R&D and Manufacturing.Used JIRA for creating User Stories, worked with Scrum team for story sizing, creation of Epic and Theme and conducted walkthrough to management by storyboard analysis.Designed and developed Business Objects based analytical platform for Sales and Marketing Analytics teams.Managed systems requirements, software requirements and business requirements on teams page in SharePoint, reviewed with teams, managed Sharepoint team site, created tasks for updates and reviews.Conducted interviews to identify objectives across: Brands, Marketing, Market Research, Sales, Training, Regulatory / Legal, IT, 3rd Party Agencies, Health Systems and AnalyticsWorked on Veeva CRM and Vault.Responsible for organizing sales/product presentations, sales proposals, providers presentations and product seminars to generate sales.Developed new business model and processes for building in-house business operations incorporating new business model processes, customer service Standard Operating Procedures, clinical trial data, and marketing/sales organization methodologiesCreated documentation and conducted design reviews for Veeva RIM integration, user security, reporting, administration.Provided clinical-study and clinical-trial support for drugs and/or medical devices through Contract research organization (CROs) specifically.Developed project plans and RACI matrix and ensures that the scope and approach are fully understood by all stakeholders.Responsible for ensuring delivery of all regulatory submission milestones and maintaining compliance with applicable regulatory obligations.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.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).Met with department managers, project manager, and Director of QA to ensure ongoing compliance with SOX, GxP, and all other applicable regulatory requirements.Prepared use cases and swim lane diagrams of the existing and to be process.Established stable Plan of Record (POR), ensured roadmap/requirements baseline, project priorities, requirements change control, driving synchronization across several development teams.Maintained integrity of data in Veeva CRM to ensure promotional items are up to date.Prepared detailed user-friendly compliance reports of the documentation for the entire project in agreement to FDA standards.Performed task decomposition, delegated tasks and monitored project milestones using MS Project.Conducted the session with business SME to gather high level requirements.Acceleron Pharma - Cambridge, MA Dec 2016 Sep 2019Business AnalystResponsibilities:Collaboratively designed policies, standards and processes that addressed issues of project resource estimating for various types of software development methodologies.Built IT request submission form and tracking workflow on SharePoint to manage change requests for commercial IT systems.Developed and evolved digital channels KPIs and measurement frameworks to align all divisions.Analyzed trends and competitor activities and makes recommendations on sales strategy.Closely interacted with Clinical Research & Development Management and Leadership teams, regarding sensitive handling of confidential information and comprehensive attention to accuracy and quality.Worked in conjunction with the Commercial, Quality and Regulatory departments to support, promote and monitor the optimal utilization of all Veeva applications to ensure departmental goals are achieved including project management, release management, requirements gathering, testing, training, and end user support.Worked with the Business Unit to understand business needs and provide effective efficient requirements for Veeva Vault, Approved Email and Veeva Engage.Accountable for the scheduling and timely delivery of packaged clinical trial material, including randomization, packaging and labeling of clinical supplies.Evaluated DR process, generated requirements, tracked and resolved project issues, and helped to create and manage User Stories in JIRA project, published JIRA Dashboard reports to team for status reporting.Conducted gap analysis, identified the potential changes and documented requirements across different systems, including CRM for a strategic initiative to enable multiple products per sales team.Performed Requirements Elicitation, Requirements Documentation and Requirements Management for Consumer Distribution IT applications that consolidates Acceleron Pharmas bulk data for Data Migration.Documented system Scope based on Product Backlog, itemized and sequenced user stories from web services development project, slotted user stories into future Sprints, worked with Product Owner and Program Management.Developed the test scripts to test the Security User Profiles and Audit Trail to meet the 21 CFR Part 11 regulations.Involved in Project Management activities like defining/managing project scope, schedule management, creating project plans, tracking and communicating project status, deliverables, and milestones.Worked with external vendors in implementing the Off the Shelf product customization and training the team members on the new product.Performed UAT based on Requirements Document and prepared the Test Cases using HP ALM/ Quality Center.Constantly groomed product backlog, received estimates from developers and QA on story sizing, details, tasks for development and delivery and documented Acceptance Criteria.Fresenius Medical Care- Lexington, MA Feb 2015 Nov 2016Business AnalystResponsibilities:Delivered guidance and support for eCube Clinicals and Chairside integration projects and responsible for the implementation of Dialysis Access Management project.Responsible for eCube Soarian implementation from Cerner, documented requirements for system rebranding and enhancements specific to Cerner executables, OPENLink and ADT messaging.Managed and updated requirements and system workflows for Dialysis Access Management application, data integration to CDS for Soarian Clinicals workflow process.Maintained the RACI matrix throughout the project cycles to assign tasks and establish accountability.Involved in identifying the problem definition as part of continuous process improvement using Define, Measure, Analyze and Improve to support the business continuity of the organization.Gathered business requirements using appropriate elicitation techniques like Observations, brainstorming, client interviewing and document analysis, conducting JAD Sessions with various stakeholders and the project team.Established Requirements Traceability Matrix (RTM) to trace the completeness of requirementsDeveloped high-level and low-level documents like Business requirements documents (BRD), Functional requirements documents (FRD) and System requirements specification (SRS).Managed Agile board in JIRA for eCube Clinicals implementation, performed daily reporting to senior management on track progress, led requirements elicitation and workshops with cross- functional tracks, documented integration points and system impact, discussed and promoted opportunities for team development.Conducted Business workflow analysis, process analysis, SWOT analysis, cost-benefit analysis and Gap analysis to know the condition of the current system in use and feasibility studies to decide necessary increments.Used Unified Modeling Language (UML) to prepare Use Cases diagrams, process flow diagrams, sequence diagrams from the gathered requirements and created diagrams using MS Visio, Rational Rose.Managed requirements for Dialysis Access Management application integration with Clinical Data Store, created wireframes for screen design Access selection screen, Pa9ent Access, Permanent Access, Pa9ent History, Events, Procedures, Infections and performed Data Modeling for DAMA.Coordinated with the Project Manager to create Work Breakdown Structure (WBS), manage schedules, deadlines, resources and the project tasks using MS Project.Developed and conducted the training schedules, user manuals, UAT and trained the business/end users.EDUCATIONMaster of Technology (M.TECH) 2004 2006Bachelor of Engineering (B.E) 1999 - 2003 |
