SUMMARY

Results driven project/program management professional, PMI PMP certified with over 16 years project management experience directing full life cycles for complex global multi-site programs. Demonstrated ability for managing global, multi-site and virtual project teams to deliver high quality, well managed, on time and on budget projects and programs. Proven ability to meet strict governmental regulatory requirements placed on the private sector for IT system compliance.

OVERVIEW OF QUALIFICATIONS

• Project and Program Management with 16 years experience, PMI PMP
• SDLC methodologies Agile, Scrum, Use Case, UML, RUP, Waterfall, RAD, JAD
• Regulated industry systems development GCP, GLP, 21 CFR part 11, GAMP, HIPPA,SOX
• Process improvement -Six Sigma, Lean, Kaizen, Total Quality Management, BPR
• Client Server Development
• Internet/Web Development
• System Architect with 14 years experience
• Business and Process Analysis with 20 years experience
• Customer Relational Management /Customer Account Management
• Presentations to C-level, International Conferences, Customer/Client meetings

TECHNOLOGY

• MS Project MS Project Server, JIRA, Visio, MS Office
• Enterprise Content Management - Documentum, SharePoint, eRoom, FileNet,
• CSC FirstDoc, QUMAS DocCompliance
• WEB/Internet - Cloud Computing, SaaS, ASP, IIS, Virtualization, .NET, HTML, Java
• Database Management Systems - Oracle, SQL Server, SAS, MS Access, DB2
• Architect - web, client server, sizing, virtualization, load balancing, terminal serving
• SaaS Business and Product development
• ePublishing Systems Liquent Insight, eCTDXpress, CoreDosier, ISIPublisher, Docutech, XML
• SAP
• Digital certificates, TLS, encryption, IPsec, sFTP, DMZ, VPN, Extranet. etc.
• Laboratory Information Management Systems LIMS

EMPLOYMENT HISTORY

Confidential

Project/Team Lead

• Responsibilities include project management of a staff of System Analyst/Developers for data integration ERH, HIE, EMR projects and application support in of several hospitals, and dozens of doctors' offices within the TriHealth network.
• Federal Government Meaningful use objective Stage 1 and Stage 2
• Epic CareEverywhere, Transition of Care, CareElsewhere
• Ohio Department of Health.Transmission/Integration of Electronic Health Record to the
• Syndromic Surveillance - Transmission/Integration of EHR
• Immunizations - Transmission/Integration of HER
• Transmission/Integration to other Hospitals in the tri-state area and US.
• Development and support if all HIE's, EHR, and EMR systems for TriHealth utilizing primarily IBM WebSphere, and Oracle's sGate.
• Data conversions and Archiving projects.
• Data Integration projects.
• Medical device integration projects into Epic.

Confidential

Project Manager/Scrum Master

• Responsible for managing regulated CFR 21 part 11 Agile and waterfall SaaS projects, new and product upgrades, Project Management deliverables and System Development Life Cycle deliverables, quality management, risk management, change management, etc. and ensuring services meet the business needs, and working closely with the clients.
• Project managed a team of Java, ASP.NET, PL/SQL, SharePoint developers, DBA, QA, BA, and end users.

Project Manager- consultant

Confidential

• Contract consultant to Merck responsible for managing a new regulated CFR 21 part 11 SaaS project with third party vendors. This project is to support the external collaboration needs between Merck and various external partners. The project manager ensure gathering business requirements, ensuring services meet business needs and identifying and implementing service improvements, establishing new products and working closely with the vendors.
• Project managed a team of Java, ASP.NET, PL/SQL SharePoint developers, DBA, QA, BA, and end users.
• In addition to SDLC deliverables, the responsibilities include resource plans, project plans, financial projections, financial variance explanations, quality management, cost management, risk management, etc,

Project Manager/Scrum Maste

Confidential

• Contract to Pfizer providing support of regulated SOX Finance and Business Operations, liaison with business partners, Business Case development, Project Management deliverables and System Development Life Cycle deliverables, quality management, cost management, risk management, and financial and ROI assessments.
• Infrastructure technical refresh project involving the installation of Sun Solaris servers , creation of zoned farm and migration of applications from un-supported versions of windows servers and out dated hardware.
• Contract consultant to Pfizer providing support of Regulatory Affairs regulated CFR 21 part 11 projects, liaison with business partners, Business Case development, Project Management deliverables and System Development Life Cycle deliverables, quality management, cost management, risk management, etc,.
• Agile/Scum Master for 7 simultaneous projects.

Project Manager- consultant

Confidential

• Contract consultant to MedImmune providing support of enterprise SharePoint CFR 21 part11 regulated projects, liaison with business partners, Business Case development, Project Management deliverables and System Development Life Cycle deliverables, quality management, cost management, risk management, etc. Project managed a team of Java, ASP.NET, PL/SQL,SharePoint developers, DBA, QA, BA, and end users.
• Managed 2.3 million dollar budget.
• Deployment of Enterprise SharePoint architecture.
• Deployment of SharePoint Clinical Document Management system.
• Integration with Clinical Trial Management system.
• Integration with Regulatory eCTD
• Electronic Publishing system.
• Managed RFP, SOW, Contracts and 3rd Party Vendors.
• Financial and ROI assessments

Project Manager/Business Architect- consultant

Confidential

• GE Micro-CT system
• Sample Tracking system
• Xybion Preclinical Lab Management system
• Contract consultant to Merck Pharmaceutical providing support of enterprise IT regulated CFR 21 part 11 projects, liaison with business partners, Business Case development, Project Management deliverables and System Development Life Cycle deliverables, quality management, cost management, risk management, etc,.
• Lean project including financial and ROI assessments

Confidential

Program Manager Professional Services

• Manage staff of Program Coordinators, Project Managers and multiple global cross-functional matrix project teams for the development, implementation/deployment of IT solutions, quality management, cost management, risk management, etc.
• Managed a team of Java, ASP.NET, PL/SQL developers, DBA, QA, BA, and end users.
• Created and defined the Program Management Office.
• Utilizing Agile/SCRUM and Lean Six Sigma, managed the product development of six new Software-as-a Service SaaS hosted regulated CFR 21 part 11 solutions and reached the highest level 4 of the SaaS Maturity Model within one year.
• Development of SaaS Business Plan, Operations Management Plan, financial and ROI assessments, SOPs and SLAs

Confidential

IT Sr. Project Manager

• Global I.S. department project manager for international cross-functional matrix project teams for enterprise and departmental IT solutions, quality management, cost management, risk management, etc. Leading teams consisting of technical resources, business analysts, vendors, off-shoring resources and business subject matter experts and stake holders. Project teams typically included Managed a team of Oracle PL/SQL, Java, ASP.NET developers, DBA, QA, BA, infrastructure and telecom, and end users.
• Recognized with 8 corporate achievements awards for leading innovation, project management and exceeding expectations on numerous IT projects.
• Successfully project managed the development, training and deployment of many regulated CFR 21 part 11 business systems typically using Oracle, PL/SQL, Java, ASP.NET and various other technologies.

Confidential

IT Manager

• Manage systems staff of Project Managers, System Analysts, and developers for clinical and regulatory Enterprise Content Management and Publishing systems, ensuring CFR 21 part 11 compliance. Manage 3rd party relationships suppliers and contract management. Serve as project manager and architect for the electronic submissions infrastructure and applications and managed the development and administration of the applications and infrastructure components including project quality management, cost management, risk management, etc.
• Recognized with 4 corporate achievements awards for leading innovation, project management and exceeding expectations on numerous IT projects.
• Managed the successful multi-million dollar full SDLC project to respond to FDA requirements to submit New Drug Applications electronically.
• Analysis of financial and ROI impacts of projects.

Confidential

Lead IT Specialist

• Project Management and Business Analysis for Electronic Submissions, global Document Management and electronic publishing systems ensuring, quality management, cost management, risk management, etc. Design and develop integrated hardware and software solutions from a variety of technologies utilizing various technologies including Oralce PL/SQL, Visual Basic, Doumentum API's, etc.
• Recognized with corporate Vision and Accomplishment Award.
• Technical lead for the global Electronic Content Management system deployed in Japan, France and USA.

Confidential

Systems Analyst

• Systems Analyst and Project Manager for globally deployed clinical and regulatory affairs systems primarily developed using Oracle PL/SQL, Documentum and SAS software. Designed, developed and supported several systems to support clinical trials and regulatory submissions publishing and tracking. Provide systems administration of VAX, Windows NT, and UNIX systems.
• Recognized with 2 corporate achievements awards for leading innovation, project management and exceeding expectations on numerous IT projects.
• Numerous business applications built using Oracle DB, PL/SQL and Oracle forms.
• Systems Analyst for the successful development and implementation of Merck Co, first Computer Assisted New Drug Application delivered to the FDA.

Confidential

Consultant

At Rorer Pharmaceuticals assigned to supporting the Clinical Data Management and Statistical departments, utilizing Oracle, Inquire and SAS.