PROFESSIONAL SUMMARY:

• 10+ years of overall IT experience with 6+ years of Business Analyst / Project Coordination and management expertise in Healthcare and Pharmaceutical Industry.
• Lead JAD sessions to aid in requirement gathering, prototyping and documentation of business and system needs via BRDs, FRDs User Stories, Use Cases, Workflows, Wireframes and Software Requirement Specifications.
• Expertise in implementing Waterfall and Agile Scrum Methodologies throughout the Software Development Life Cycle of the project.
• Strong knowledge in pharmaceutical/medical device regulations such as FDA 21 CFR Part 11.
• Extensive experience in HIPAA, ICD 9/10, Crystal Reports and MDM
• Implemented Unified Modeling Language (UML) methodologies to design Use Case Diagrams, Data Flow Diagrams, Activity Diagrams, Sequence Diagram and ER diagrams
• Responsible for Gap analysis in HIPAA 4010 to HIPAA 5010.Incorporated and implemented all the HIPAA standards, Electronic Data Interchange (EDI), transaction syntax like ANSI X12, ICD - 9, ICD-10 coding.
• Adequate knowledge in Healthcare Administration - Claims processing (auto adjudication), COB, EOB/Drafts, Claims pricing and testing, HIPAA, Pre authorization, enrolment, EDI, Medicare, Medicaid, CDHP (consumer driven health plans).
• Strong knowledge of FDA QS, CFR 211 for Pharmaceutical, Clinical Trial, Life Science and Health Care Industries.
• Excellent experience in working with FDA regulated environment, GxP (GCP/GLP/GMP) guidelines.
• Strong Working Knowledge of SDLC, GRC 21CFR Part 11 and software FDA validation practices
• Involved in Trouble Shooting, Performance tuning of reports.
• Automating import of data into the application. Submission, error resolution, and audit CMS (PDE and RDS).
• Worked closely PMO on Duration Analysis, Cost Benefit Analysis and RACI Analysis.
• Extensive experience in using Microsoft Visual studio suite and HP ALM for writing functional and non-functional User stories and test cases.
• Has experience in conducting Unit Testing, Integration Testing, System Testing, User Acceptance Testing (UAT) and documentation of test cases. Expertise in designing and developing test plans.
• Ability to organize, document and track changes and defects using JIRA, Rational Clear Quest and archive change request in Clear Case
• Extensive experience in using business process tools such as MS Project, MS Excel, MS Access, MS Visio, technical assessment tools, Business objects.
• Excellent Team player and capable of working independently, with excellent communication and interpersonal skills.

TECHNICAL SKILLS:

Methodologies: SDLC, Agile Scrum, Waterfall, UML

Testing Tools: HP ALM,(Test Director / Quality Centre), QTP, Win Runner and Rational Suite

Change Management Tools: Rational Clear Quest, Rational Clear CaseQuality / Statistical Tools: Six Sigma, SPSS

Business Modeling Tools: Rational Rose, MS Project, MS Visio

Programming Language: C, C++, Visual Basic, .Net, JAVA, SQL, PL/SQL XML

Project Management: Microsoft Project, Microsoft Office

Database / Data warehouse Tools: MS SQL/PL SQL

Informatica Documentation Tools: MS Office, Adobe Acrobat

Web Technologies: CSS, HTML, XSL, XML, ASP, JavaScript MS Front Page and Dream weaver 2004

Requirement Gathering Tools: Requisite Pro

Content Management Tools: JIRA, Confluence

PROFESSIONAL EXPERIENCE:

Confidential, Edison, NJ

Business Analyst / Ass. Project Manager

Responsibilities:

• Actively involved in assisting the development of Project charter to gain approval from project sponsors.
• Assisted in Identifying project team members (Onsite and Offshore) and understood their roles and responsibilities to help develop communications plan.
• Actively involved in requirement gathering and requirement management by collaborating with different stakeholders.
• Analyzed requirements, assigned attributes and segregated them into high-level and low-level use cases.
• Verified Use-Cases, Wireframes and Activity Diagrams to demonstrate business process flow and interaction of system components before prototyping. Helped in Creating workflow diagrams with the help of UML through MS Visio.
• Helped the team in developing requirement traceability matrix.
• Worked with QA team to help with User Acceptance Testing, developing and maintaining quality procedures, and ensured that appropriate documentation is in place.
• Worked with development and testing teams to accomplish timely release objectives.
• Organized weekly Bug Triage meetings with the development team and testing team to clear any pending tickets in regards to bug fixing.
• Helped in planning for extensive Communication and Stakeholder Management techniques as the project has a higher stakeholders’ visibility.
• Helped PM in Managing the delivery for all the applications under Portfolio using various technologies MS .Net, Ms Sql, ERP (PeopleSoft), ETL (Abinitio) and Reporting Tool (Business Objects).
• Coordinated the work of 4 onshore Leads and 2 Vendor resources and 15 offshore team members.
• Maintained shift roaster for applications as per support hours.
• Responsible for presenting weekly status report to Production support and Application Managers and monthly Reporting to Senior Management. Involved in creating user guide and trained end users.
• Created process improvement documents for Service Request Management.
• Created Issue Records Report for all the portfolios and used to track the progress through Issue management call.
• Helped in maintaining quality artifacts for Internal /External Audit process
• Used MS SharePoint for Team collaboration and to build Knowledge base.
• Actively participated in facilitating project meetings with Stakeholders and Project Delivery team.
• Supported the PM who was the single point of contact for all the applications supported under portfolio to manage project timelines by using MS Project.
• Created project reports and documented stakeholder feedback to gather inputs for the next version update.

Confidential, Lake Bluff, IL

Business Systems Analyst

Responsibilities:

• Was involved in understanding requirements to Integrate IRep tool with 1Connect, designed to allow reps to drop samples or order samples and place customer orders, estimate delivery date and track shipments.
• Facilitated JAD sessions to gather business requirements by interacting with stakeholders, Subject matter experts, created requirements documentation and drafted minutes of the meeting with Action Items and Parking Lots.
• Participated in creating and documenting GAP analysis.
• Worked closely with Project Manager and Team leads in scheduling Project deliverables and Time lines using MS project.
• Created Use case documents and diagrams to clearly identify the primary, alternative (Sub) flow, system boundaries and assumptions.
• Helped in creating wireframes to do screen mockups.
• Created Activity diagrams using MS Visio to describe the dynamic behavior of the system.
• Worked with the test and development teams, assisted in creating TDD.
• Facilitated weekly team meetings. Also scheduled bi-weekly meetings with clients.
• Developed documentation and deliverables dictated by the System Development Life Cycle (SDLC) and client Integration Life Cycle (IPLC).
• Jointly worked with Test lead to create Test Plan and conducted UAT
• Actively participated in creating User training manual, End user training, conducted knowledge transfer sessions and Handled change request and change management issues.

Confidential, Minneapolis, MN

Business Analyst

Responsibilities:

• Responsible for identifying and documenting business needs of clients and stakeholders to help determine technology solutions available.
• Focused on collating information from Pre-clinical trials by partnering with the Safety Assessment and Laboratory Animal Resources (SALAR) organization.
• Captured requirements from SALAR employees to help develop system to analyze experimental data and integrate it with qlickview reporting tool to dashboard Pre-Trial reports in a complaint IT environment to submit to clinical trial registry for FDA approval process.
• Worked with SALAR employees who assess implications for human safety and capture /analyze experimental data, and report findings in an compliant IT environment.
• Interviewed Clinical Trail business area experts, other stakeholders to create CSR ( Clinical Study reports ) requirements documentation in alignment with PhRMA-EFPIA principles for responsible CSR, understandable by Technical and Business counterparts.
• Created Validation documentation such as IQ’s, PQ’S, Process validation, cleaning validation and software validation to be compliant with CGMP
• Wrote documentation for all aspects of the computer systems validation lifecycle in accordance with FDA regulations particularly CFR 21 part 11, validating processes and equipment utilized to manufacture active pharmaceutical ingredients/ Drug administering Equipment in an FDA approved environment.
• Performed unit and regression testing along with the QA team.
• Involved in weekly walkthroughs, inspections and verification meetings with various stake holders in the project.
• Was accountable for Quality Assurance to ensure that all requirements have been successfully tested.

Confidential, Aliso Viejo, CA

Business Analyst

Responsibilities:

• Facilitated collection of User Requirements and Business Requirements from Business User Groups.
• Identified system integration requirements, coordinated the collection and verification of business needs to reach Requirement Validation Specification, Detailed System Design Documentation Milestones.
• Reviewed and Authored Standard Operating Procedures (SOP) and trained all users on these systems and the implications and impact of CFR 21 part 11 compliant data systems on day-to-day functions.
• Developed Traceability Matrix using Rational Requisite Pro.
• Helped in creating Wireframes for better Stakeholder engagement and to aid end user training.
• Worked on integrating Ambriport to Insurance providers for Preauthorization requests.
• Documentation, validation and approval of Business requirements.
• Handled Change Requests and taken care of Approved Changed Requests from impact analysis to delivery.
• Developed and reviewed test, validated test cases and business functional scenarios using HP ALM.
• Conducting test team meetings and involved in developing test plan to accomplish the overall objectives for the time period.

Confidential, New York, NY

Business Analyst / Project Coordinator

Responsibilities:

• Conducted JAD sessions with business users, stake holders, vendors and IT team to gather, review and document requirements . Created Business Requirement Documents (BRD) and Functional requirement Specification (FRS) for the project and conducted cross functional reviews.
• Worked closely with the PM to Finalize Scope, Timelines, project deliverables using MS Project.
• Assisted PM in recording Minutes of the meeting.
• Assisted in conducting weekly core team meetings and created an issue log to track the project.
• Worked on Impact analysis for each of the requirements and their sub entities(segments).
• Creating RTM to trace between business requirements and scope.
• Created Requirement Action Plan for the project deliverables.
• Extensively worked on SharePoint tool for document management.
• Worked with the customer service team to analyze per call time/ count data for generating management level reports.
• Worked with AVAYA software to get the required data for customer service reports
• Reviewed CMS regulation and created business requirement for collection server (edge server)
• Created Test cases and participated in Unit testing.

Confidential, Jersey City, NJ

Business Analyst/ Project Coordinator

Responsibilities:

• Helped Project manager in conducting Daily Scrum meeting and tracked progress using burn down chart.
• Assisted Project manager in tracking scope changes, Identification of new Risks to update risk response plan.
• Ensured the project deliverables conformed to the quality standards established in the project quality plan.
• Monitored cost, schedule and resources to meet deadlines adhering to quality standards.
• Responsible for creating user stories, verify and validate from stakeholders.
• Prepared the Test plan and monitored Test Deliveries.
• Identified and maintained required artifacts for the project as per QA standards.
• Responsible for weekly and monthly reporting to Stakeholders.
• Extensively worked on SharePoint tool for document management
• Implemented Waterfall methodology for (1.0 - 1.2) Release and Agile for 2.0 Release.
• Coordinated with various teams i.e. onshore, offshore, DB team, QA, Development and support Team for configurations and deployment.

Confidential

IT Coordinator

Responsibilities:

• Assisted PM in facilitating discussions and Collaborated with Technical team to delineate user requirements.
• Translated requirements into a global LIMS and assisted in the design of solution and its review with all stakeholders.
• Involved in documentation approvals.
• Helped Project manager to conduct Meetings periodically with SMEs at various phases of the Software Development Life Cycle (SDLC) to discuss open issues.
• Used MS Project to manage schedules, deadlines, and resources collaboration.
• Coordinated with the System Analyst to authorize System Requirements based on the Business Requirement Documentation.
• Analyzed specifications for customization of the software, which included configuration in LIMS Basic, Crystal Reports and SQL. Responsible for assigning work to team members, providing weekly status to Project Manager.
• Assessed Change Controls and implemented necessary changes in LIMS.
• Development and implementation of the Global LabWare LIMS system for Orchid.
• Worked on assisting development of Environmental Monitoring Program in LIMS.
• Involved with the investigative site on issues concerning current clinical trials.
• Handled change requests and updated documents related to change.