SUMMARY

• Highly motivated, action - oriented and results driven Information Technology leader with over 15 years of experience as a Project Manager effectively leading cross functional project teams to meet organizational objectives. Strong problem solving and analytical skills, with outstanding interpersonal skills.

PROFESSIONAL EXPERIENCE

Project Manager

Confidential

Responsibilities:

• Developed RFP and vendor score card.
• Worked with Starlims on gap analysis and SOW.
• Developed and managed budget and project schedule.
• Developed risk plan and risk assessment.
• Documented as-is and to-be workflows for clinical trials and diagnostic testing.
• Managed integrations to instruments as well as Microsoft Dynamics NAV ERP System
• Managed the development and execution of IQ, OQ, PQ as well as master validation plan and traceability matrix.

Remote Program/Project Manager

Confidential

Responsibilities:

• Manage project from initiation through project closure.
• Manage on-shore and off-shore teams for the development of LIMS which includes: sample management, test methods, worksheets, configuration management, user administration, instrument interfaces and SSRS reporting.
• Manage the development and approvals for requirements, risk assessments, test plan, traceability matrix, release management plan, support plan, validation plan, IQ-OQ-PQ protocol and test case execution, validation summary report and the development of SOP’s.
• Create and maintain project schedule, issue log, budget, risk management, burndown charts, and KPI’s and status reports.
• Manage infrastructure team to set up seven hardware environments.
• Develop and present slides to the Executive Steering Meeting Committee for Status Reporting and Stage Gate Exits.
• .Net environment, SQL Server, HP/ALM, Workfront

Sr. Project Manager

Confidential

Responsibilities:

• Worked with the management team through the vendor selection process.
• Created and maintained RFP, project schedule, budget and status reports.
• Managed Perkin Elmer and internal personnel for the scheduling of equipment down-time for qualification within 12 laboratories.
• Managed IQ, OQ and PQ development and execution.
• Created Qualification Summary Report for all devices.
• Developed business case for LIMS software and note books.

Program/Project Manager

Confidential

Responsibilities:

• Manage teams that consist of Business Analyst's, Developers, Architects, Testers and Vendors.
• Develop and maintain project schedule, budget, risks, and issues logs.
• Work with the business to develop SOP’s and training materials.
• Project Manager for the divestiture of Confidential Regenerative Medicine. Project managed the transition and integration of IT Infrastructure, Applications, Web Domains and Web Sites to Organogenesis.
• GMP, 21 CFR Part 11 Compliance, IQ,OQ,PQ Protocols.

Program/Project Manager

Confidential

Responsibilities:

• Led development team through a vendor selection process for a Laboratory LIMS solution. Developed score card and worked with various vendors.
• Worked with internal business and developed requirements for SaaS portal solution for Confidential ’s CLIA Laboratory, and led team through the vendor selection process.
• Developed budgets, project schedules, status reports and communication plan. Manage risk, issues, and validation plan. Create and present presentations for phase stage exits.
• .Net, Java, and SQL environment HL7 and Web Services integrations.
• 21 CFR Part 11, HIPAA Compliance.

Sr. Project Manager

Confidential

Responsibilities:

• Project Manager for highly regulated projects across enterprise-wide laboratory information systems.
• Manage business analysts, developers, architects, and off-shore testers through Agile SDLC for the development of the following systems:
• The development of a custom regulated system called PRO that creates test results from various laboratory information systems. PRO integrates through HL7 interfaces and web services to laboratory information systems, instruments, billing system, and reporting systems.
• The development of graphical test reports that are generated and delivered through web services to Quest’s Care 360 portal for hospitals and physicians to review and download.
• Led business through the vendor selection process for an Enterprise Anatomic Pathology Solution.
• Utilize Clarity to manage projects, budgets and for time keeping.
• Utilize agile methodology. Java, Flex, and Oracle environment.
• 21 CFR Part 11, HIPAA Compliance.

Project Manager/Business Systems Analyst

Confidential

Responsibilities:

• Managed the development of a custom laboratory information system and a web portal for clients to access test results. Project consists of receiving orders electronically, to sending test results and reports through an HL7 Interface to various EMR’s. Development of system is done off-shore with a vendor.
• Responsibilities also include working with the business to develop business requirements and functional specifications.
• .Net environment.
• 21 CFR Compliance and CLIA Regulations.

Sr. Project Manager/Business Systems Analyst

Confidential

Responsibilities:

• Managed the development of a New Product that will capture ventilator data at point of care and electronically send data into hospitals electronic medical record system. System interfaces through HL7 interface with external systems to create an EMR record, alerts for clinicians and reporting trends for data analytics.
• Responsibilities consist of managing user needs, user stories, requirements, project schedule, budget, systems hazards, and project charter.
• Utilized Team Foundation Server for requirements, specifications and development iterations.
• Worked with Clinicians and Focus Groups to develop current and future state workflows.
• Worked with developers to design screens in Sketchflow and Silverlight. .NET Environment.
• GMP Compliance.

Senior Project Manager/Business Systems Analyst

Confidential

Responsibilities:

• Project managed multiple projects for the following:
• The development and implementation of a new underwriting application that was developed off-shore
• Project managed the development of an Integration layer (ESB), so Insurance Companies of the West could integrate with multiple systems. Schemas were developed using the ACORD standard.
• Responsible for setting up a new integration environment for Predictive Analytics which included setting web applications that interfaced with outside sources as well as interfacing to in-house legacy system. This integration environment consists of IBM Mainframe (Cobol, JCL, and RDBMS), SQL server, Cold Fusion, ASP, Java.
• Managed project schedule, risks, and budget.
• Managed business analysts and testers through the development of requirements, specifications, test plans, and test cases.
• Managed infrastructure and security teams for setting up servers and user security.

Project Manager/Business Systems Analyst

Confidential

Responsibilities:

• Primary Liaison between Business units and the Technology group for the design and implementation of a new Broker Point of Sale System and a Branch Pricing Portal. This portal interfaces directly into the Loan Origination System, MindBox Automatic Underwriting, Pricing and FileNet imaging system.
• Held JAD sessions, developed requirements, and managed off-shore developers.
• Managed the implementation of MindBox pricing engine.
• SQL, Java and .Net environments.

Project Manager/Business Systems Analyst

Confidential

Responsibilities:

• Project managed the development of an Enterprise Mortgage Solution, by developing a Service Oriented Architecture which utilizes Web Services, ESB, Workflow Management (BPEL), Business Process Management, and “Best of Breed” solutions for wholesale, retail, prime, and non-prime business channels.
• Managed the development of Internet and Intranet.
• Project managed the in-house development and implementation of an imaging system through Agile Life Cycle. Developed Requirements, test plans and test cases.
• Project managed various vendor implementations including Pricemyloan, DISSCO for fraud, Great Plains Accounting Software, Intellimine Data Warehousing, and MindBox Automatic Underwriting and Pricing System.
• Created requirements and vendor score cards. Developed and documented the current business processes as well as “Best Practices” utilizing Proforma Corps, Provision ProcessPro Software.
• Developed Software Development Life Cycle’s utilizing Agile and Waterfall methodologies.
• Developed and managed budget, project plans and requirements.
• SQL, Oracle, Java and .Net environments.