CHRONOLOGICAL SUMMARY OF EXPERIENCE:

Confidential

Senior Consultant

I am working as a senior Business Analyst to support multiple systems for several business areas: Sales, Sales Operations, Sales Training, Quality Compliance, and Data Management. Those systems are including Veeva Customer Relationship Management CRM system, Veeva Data Integration Layer DI , Critical Business Processes CBP, for Change Requests and Sample Eligibility Validation , Commercial Data Warehouse System CDW , Master Data Management System MDM , BI Cognos Compliance Reporting System, Field Ride Request System, Otsuka Business Institute OBI, a learning tool for sales force etc.

ROLES AND RESPONSIBILITIES:

Project Management

• Gathered, maintained and prioritized system requests, including bug fixes and enhancements.
• Grouped, tracked and managed requests in production releases.
• Planed and tracked production releases to align with other projects undergoing and sent status report to the business and IT teams.
• Assigned technical resources for each enhancement request.
• Actively supported Senior Customer Engagement Manager/ Senior Project Manager of commercial IT to track action and open issues/items and define project scope etc. for various IT projects.
• Oversaw system testing activities for CBP and CDW.
• Worked closely with Otsuka Strategic Sourcing group in vendor selection process for Field Ride Request system: summarized the strategic goals of the project, provided high level requirements in Request for Proposal RFP , responded to questions from vendor, and reviewed RFP and vendor proposals.

Business Analysis

• Gathered and documented requirements for new IT systems and enhancements to existing systems through JAD sessions, interviews, use cases, user story, prototyping and white boarding etc.
• Extensively interacted with technical teams to understand and document system workflows, data flows, trust/ survivorship rules, functional specifications and data integration specifications.
• Coordinated with Testing Validation team in developing testing scenarios and solving deviations.
• Built IT request submission form and tracking workflow on SharePoint to manage change requests for commercial IT systems.
• Played an important role in launching FDA-approved new product and new sales force into the CRM system by conducting impact analysis and documenting requirements
• Documented user and functional requirements for a healthcare professional HCP look-up tool between Veeva CRM and the third party IMS HCP database.
• Articulated business rules, developed process diagrams, and authored user requirements specification for HCP address verification and overall sample eligibility validation to ensure the systems meet the compliance requirements.
• Created user requirements specification and functional requirement specification documents for BI Cognos Compliance Reporting system, conducted Quality Assurance of those reports and identified data issues and gap.
• Conducted gap analysis, identified the potential changes and documented requirements across different systems, including CRM, DI, MDM etc. for a strategic initiative to enable multiple products per sales team.
• Gathered requirements for adding promotional items including samples, vouchers, co-pay cards and demo kits etc. into the systems and tracking/ reporting distribution of promotional items.
• Re-designed work flow for field ride request process and documented user requirements.
• Updated URS, created System Testing Plan STP and reviewed the executed STP and System Testing Report STR for CBP phase II
• Executed UAT test cases for OBI using HPQC and Veeva system.

Environment: MS Office Word, Excel, PowerPoint, Outlook , MS SharePoint, MS Visio, MS Project, Veeva CRM, Salesforce, Data Warehouse, Master Data Management System, BI Cognos Reporting System, EDMS, HPQC.

Confidential

I played a short term validation specialist role to validate Veeva CRM system, a Salesforce integrated solution with Sample Management and Signature Capture functionality for Pharmaceutical and Life Science companies to be compliant with 21 CFR Part 11 and Prescription Drug Market Act detailed in 21 CFR Part 203 regulations.

ROLES AND RESPONSIBILITIES:

• Reviewed Validation Plan, Business Requirement Documents, Validation Summary etc.
• Created and executed IQ and OQ test scripts to verify sample inventory, sample transaction and disbursement, e-signature capturing functionality, etc.
• Tested the system on different platforms, including PC/Laptop/Tablet Windows , PDA Windows Mobile and iPad OS X .
• Created incident reports and solved the deviations.
• Supported other team members to validate/qualify TrackWise, LIMS, ELN and Lab Equipments, etc.

Environment: MS Office Word, Excel, PowerPoint, Outlook , MS SharePoint, MS Visio, MS Project, Veeva CRM, Salesforce.

Confidential

As a Senior Business Analyst/ Project Manager, I was working on strategic proposals and projects to support Clinical Development, Clinical Operations and Global Drug Safety departments.

ROLES AND RESPONSIBILITIES:

Project Management

• Initiated and planned two projects for Investigator Database and Investigator Site Startup Tracking Tool.
• Prepared business case and project justification presentation slides for senior management.
• Created project charter, identified the business problems and desired business outcomes, defined the project scope, key success factors, project team and roles and responsibilities.
• Combined both SDLC and Agile methodologies for project planning and management.
• Broke project down to detailed tasks and estimated duration, efforts and resource requirements for each task.
• Conducted technology comparison, tool/solution assessment and solution selection from several potential solutions, including SharePoint, Clinical Trial Management System CTMS and customized systems.

Business Analysis

• Interviewed with stakeholders/SMEs to understand the business problems and processes, and gather business requirements.
• Analyzed adverse event submission/ distribution S/D rules, conducted data modeling, converted user requests to the actual S/D rule changes and designed a standard user request form to capture more accurate information.
• Participated in testing/ validation of Individual Case Safety Report ICSR Data Quality Review SharePoint portal, which serves as a bridge between two regulated systems: Adverse Event Global Information System AEGIS and Document Management System.

Environment: MS Office Word, Excel, PowerPoint, Outlook , MS SharePoint, MS Visio, MS Project, Metastorm ProVision, HP Project and Portfolio Management Center PPM , Clinical Trial Management System CTMS , Adverse Event Global Information System AEGIS .

Confidential

As a senior business analyst within the Project Management Office PMO , I supported several projects and operational initiatives for the NJ state Medicaid Managed Care program, including ICD-10 implementation, appropriate use of NICU Neonatal Intensive Care Unit days, claim adjudication system McKesson ClaimCheck configuration, HIPPA 5010 upgrade for encounter processes, etc.

ROLES AND RESPONSIBILITIES:

Project Management

• Supported the team for project opportunity assessment and gate reviews.
• Identified the project scopes and interdependency of under going projects based on the impact analysis.

Business Analysis

• Conducted meetings and interviews with business stakeholders/SMEs to document their current state business processes and future state processes in SIPOC and process map documents.
• Assessed the potential impact of ICD-10 implementation across various functional areas, including Provider Contracting and Servicing Physician, Ancillary and Hospital Contracting , Health Services Care/Case Management, Disease Management, Utilization Management, NICU Program, Quality Management, etc. , Pharmacy Pharmacy Benefit, Utilization etc. , Administrative Services Third Party Administrator, etc. , Vendor Systems Management Claim Processing, Encounter Processing, etc. , Informatics and Reporting Data Warehouse, Business Intelligence, etc .
• Guided junior business analysts for process impact analysis.
• Developed remediation item list for ICD-10 implementation.
• Completed all training for Horizon Six Sigma Yellow Belt program

Environment: MS Office Word, Excel, PowerPoint , IBM Lotus Notes, MS SharePoint, MS Visio, MS Project, Process Document System, Planview.

Confidential

I worked on multiple projects to support several systems, including the Lab Information Management System LIMS , Customer Relationship System CRM and Enterprise Resource Planning ERP system etc.

ROLES AND RESPONSIBILITIES:

Project Management

• Managed implementation of CRM and dropbox and courier management module in a customized LIMS.
• Created the project plan and track projects against the plan.
• Engage outside solution vendor and coordinate with in house technical team for system configuration, integration, testing and training.

Business Analysis System Support

• Interviewed business stakeholders from various business areas, analyzed their current business processes and problems, drew process diagrams, and proposed future processes.
• Gathered requirements for CRM, Inventory and Quotation modules of ERP system.
• Worked closely with business users, in-house technical team and external vendor to conduct data mapping and migration, system configuration/customization for the ERP system.
• Conducted data modeling for data warehouse and analyzed business intelligence and data reporting requirements to build dashboards for senior management team.
• Performed daily support for the customized LIMS for bug fix and enhancement request.
• Conducted system trouble-shooting with in-house developers.

Environment: MS Office Word, Excel, PowerPoint , MS Outlook, MS SharePoint, MS Visio, MS Project, Epicor ERP, cLIMS, CRM, Sales Force.

Confidential

There was a data storage challenge in multiple research areas in Drug Discovery and PreClinical Sciences DPS at Merck. This project was to collect requirements from different groups about the scope, scale, and workflow requirements of data storage needs to help with the design of a general DPS data storage system. Majority of data needing storage solution were imaging data.

ROLES AND RESPONSIBILITIES:

Business Analysis

• Interviewed stakeholders from more than 13 research groups to understand their current work flows and ideal work flows, drew process diagrams, and analyzed gap between the current process and the future process.
• Conducted surveys and questionnaires to gather information from users, including their daily operation, data storage challenges, data flow, current data volume and the future data generation rate etc.
• Analyzed information from users and documenting requirements.
• Evaluated and compared different potential solutions for laboratory data management, including IDBS BioBook, Agilent OpenLAB, IBMS iSCORE, etc.
• Interacted with technical and solution delivery team to ensure the information is sufficient for them to design a solution.

Environment: MS Office Word, Excel, PowerPoint , MS Outlook, MS SharePoint, MS Visio, MS Project, FirstDoc Documentum, IDBS E-WorkBook BioBook, CyberLAB/OpenLAB, .

Confidential

Senior Business Analyst

I worked as a senior business analyst and validation project manager. There were two regulated systems I was supporting: the Statistical Analysis and Reporting System STARS and the Quality Compliant Investigation System QCIS . STARS is a suite of front end applications modules that interface between the users and the Statistical Application System SAS to facilitate the users from the Stability, Biological and R D groups to interact with the SAS package. QCIS is an enterprise-wide web application to collect, manage and investigate quality complaints from different sites and markets globally where BMS is conducting its business. Multiple projects were on-going to validate these two systems and develop and implement new enhancement/bug-fix patches for them.

ROLES AND RESPONSIBILITIES:

Project Management

• Played a management role for two regulated computer systems throughout software development life cycle SDLC .
• Worked with the business owner and system owner to conduct project planning, budgeting and resource allocation.
• Interacted with software vendors, web engineers and database administrators to ensure new systems/patches to be delivered and implemented on time.
• Worked closely with Quality Assurance QA person to facilitate system periodic review, internal audit and

Business Analysis System Validation/ Support

• Interviewed business users to understand their current business process, provided suggestions on process improvement, drew process diagrams, and analyzed gap between the current process and the future process.
• Conducted JAD sessions, meetings and interviews to gather user requirements and functional requirements.
• Conducted system administration, support and trouble shooting for end users.
• Worked with developers to investigate and identify the root reasons for system bugs.
• Developed and executed SQL scripts to generate various reports from Oracle databases.
• Provided analysis report on the incidents/deviations and participated in corrective actions and preventive actions CAPA .
• Participated creation and validation of the interface between STARS and Laboratory Information Management System LIMS .
• Authored Risk Assessment, Part 11 Assessment, User Requirements Specification, Functional Requirements Specification, Design Specification, High-level Architect and Standard Operation Procedures SOP to reflect the future system.
• Created and/or updated Validation Plan, Installation Qualification IQ Protocol, Operation Qualification OQ Protocol, Performance Qualification PQ Protocol, Test Scripts, System Testing Summary, User Acceptance Testing UAT Summary, Traceability Matrix and Validation Summary to assure user requirements and functional requirements are satisfied in the system.

Environment: MS Office Word, Excel, PowerPoint , MS Outlook, MS SharePoint, Remedy, Trackwise, Documentum including Webtop, Valdox and Epic Star , HPQC, QCIS, STARS, SAS, LIMS, MS Visio, MS Project, Enterprise Architect.

Confidential

The project was to upgrade and implement the Assessment Management System AMS , a part of the WyethTRAINet Learning Center solution. The WyethTRAINet Learning Center is a web-based enterprise wide learning management system which may be used for, but not limited to, schedule and administer examinations, distribute new education and provide knowledge certification and career advancement courses. The AMS is implemented to administer examinations, acknowledgements and games, and to record the results of exams and acknowledgements for potential cGMP regulation purpose. It interfaces with the SumTotal TotalLMS Learning Management System LMS portion of WyethTRAINet Learning Center and is launched from the WyethTRAINet Learning Center web portal within the InsideWyeth intranet website.

ROLES AND RESPONSIBILITIES:

Business Analysis System Validation

• Acted as a key liaison between business users and technical team or vendor.
• Worked closely with end users and IT development staff throughout requirement-gathering, analysis, design, development, testing and implement phases of the SDLC.
• Conducted JAD sessions, workshops and interviews with business and technical Subject Matter Experts SME to gather user and functional requirements.
• Helped business users to perform Return on Investment ROI analysis and evaluate different software solutions.
• Analyzed the gap between As Is and To Be and conducted business process reengineering/ modeling and optimization for the future system.
• Created User Requirements Specification, Functional Specification and Use Cases.
• Analyzed the system by creating various diagrams: business process flow diagram, use case diagram, data flow diagram and deployment diagram.
• Assisted project manager to schedule meetings, allocate resources, calculate cost and set up project milestones and timeline.
• Involved in System Integration, Configuration and Customization, Interface Design, Data Analysis/Mapping, and Data Migration/Conversion and provided detailed process diagrams for the technical team.
• Participated in creation or review of Regulatory Assessment, Risk Analysis, Validation Plan, Interface Installation Qualification IIQ , Application Installation Qualification AIQ , Operation Qualification OQ Protocol, Performance Qualification PQ Protocol, System Performance Qualification SPQ , Testing Summary Report, Overall Validation Summary and other validation deliverables.
• Created OQ, PQ and SPQ test cases and executed OQ scripts for System Testing, PQ scripts for User Acceptance Testing UAT and SPQ scripts for System Performance Testing.

Environment: MS Office Word, Excel, PowerPoint , MS Visio, MS Project, Enterprise Architect, TIBCO Business Studio EAI, Novell GroupWise, MS SharePoint, e-Room, Documentum including EDMS and GCMS/GxPharma , Pedagogue AMS, SumTotal TotalLMS.