SUMMARY:

• Senior Program/Project Management professional focused on developing and executing business strategy and enabling information technology solutions for industry leading companies to meet or exceed their business objectives.Proven experience in delivering high visibility/risk $5 - $25M+ enterprise implementations and project turnarounds.
• Business and Information Technology Project Management Leader with 20+years’ experience leading and delivering the client’s global and domestic strategic enterprise project initiatives within the financial services, pharmaceutical, and healthcare industries.
• Cross disciplinary project delivery experience (R&D, pre-clinical, clinical, laboratory, drug safety, regulatory compliance, product development, marketing, sales, information technology, human resources, operations, and call centers/customer service).
• Extensive experience in all areas of Information Technology including: IT Governance, Risk, & Compliance, IT Investment (Business Case, Build vs. Buy decisionsRFI/RFP IT solution/vendor selection including esourcing systems), Program Budgeting/Financials, PMO, Program, Portfolio and Project Management methods, processes, and tools, business process improvement, full SDLC processes, enterprise COTS package solution selection and implementation, software development (managing on-shore & off-shore development global teams/resources/vendors), BCP/DR and IT Infrastructure deployments.

AREAS OF EXPERTISE:

• Financial Services - (Credit Card, Insurance, Retail Banking)
• Human Resources Management Consulting
• Drug Development &Clinical Trials - Processes - Adaptive Clinical Trial Designs, Supply, Registration & Result Posting - Systems CTMS (Inform), Electronic Data Capture EDC (Medidata RAVE, Oracle Clinical), IVRS, CDM, LIMS, Drug Safety SAE,
• Sales, Marketing, Customer Loyalty, Campaign Mgt.
• Web Application Development
• Global Records Mgt. & eDiscovery
• IT PMO Governance, Procedures, & Tools
• Portfolio Planning Business Cases, Strategic Alignment, Prioritization
• Budget & Vendor Management Software Vendor RFI & RFP development for COTS Solution Evaluation & Selection Assessments, Audits, and Management
• IT Business Continuity& Disaster Recovery Planning
• Quality Management System Development
• Portfolio &PMO Governance,Program & Project Management PMP (PMBOK)
• GAMP5 Systems Development Life Cycle SDLC Computer Systems Validation
• Agile/Scrum PM Software Development
• Process, Use Case and Requirements Modeling using Visio, RUP, &UML
• Six Sigma (DMAIC & DFSS/DMADV) - Business Process Analysis, Design & Improvement
• IT Service Management ITIL v3
• Pharmaceutical ISPE GAMP5
• Computer Systems Validation, (GxP, GCP, GLP, GMP)
• FDA 21CFR Part 11 Quality Management Systems QMS Prescription Drug Marketing Act PDMA
• Privacy - HIPAA & EUSafeHarbor
• Internal and FDA/EMEA IS Audit Preparation & Management
• Regulatory Records Retention Requirements
• FDA Amendments Act (FDAAA) of 2007
• ICD 10 Remediation
• MS Office Project Professional 2013
• MS Office Enterprise Project Server 2010
• MS Office Project Portfolio Server 2007
• MS Office SharePoint Server 2007 (MOSS), WSS 3.0
• MS Office 2013
• OPX2, Matrix Clinical Trial Resource Planning and Forecasting System
• MS SharePoint & eRoom(Documentum)
• Adobe Professional, Cerity ECM, Teleform OCR,FileNet (Panagon), Documentum ECM v4&5, MS Records Center 2007,Onbase
• Siebel eBusiness 2000
• Business Change Management - business process redesign, SOPs
• Microsoft Platform - MS SP/HTML/XML/, .Net Framework, Active Directory LDAP
• Java Platform - Visual Caf 4.1, java - J2EE, Java1.2, javadoc, swing JSP, junit, java script
• Oracle 9i, 10G, 11i, 12G
• MS SQL Server 2000, 2005, & 2008 SSRS
• ERWin SQL script
• MS Visual Source Safe, CVS, Jira Bugzilla, Subversion
• HP Quality Center 10.0, ALM
• Service Center 6.2 Remedy, Magic, BMC Svc Desk, ServiceNow
• BI/Reporting Tools - Business Objects 5.1 Crystal Reports 9.5
• Cognos OLAP Cubes, Dashboards, QlikView
• UNIX/LINUX Servers
• Windows 2000 & 2003, 2008 R2 Servers w IIS, Stratus hardened Servers
• Virtualized Microsoft and Linux servers
• VMware VDI, Citrix
• BEA Weblogic 5.1,6,8.1 IBM MQ Series
• TIBCO eGate
• EMC & Hitachi SAN Storage
• System monitoring - HP OpenView, Solarwinds

PROFESSIONAL EXPERIENCE:

Confidential

Senior Program/Project Manager

Responsibilities:

• I have proven experience leading large healthcare IT systems projects and implementations.
• Led the technical project implementation for a multi-year/$20M Enterprise implementation of Epic 2015 (Ambulatory, Ancillaries (Lab, Radiology, etc.), and Inpatient (700+ beds)) (6,000+ clinicians) including technical Cutover/Activation and Command Center planning/execution, test and production failovers. Implemented Epic HIM/Identity module and six legacy data conversions into Epic.
• Led the planning and implementation of all Epic readiness technical infrastructure (build out, full production data center failover testing, development and execution of Epic go live/activation technical cutover plan) and business continuity/disaster recovery solutions (Epic Downtime Solutions (SRO, BCA Web, BCA PC, and BCA Web Data Entry) efforts for Epic Implementation Go Live Readiness across all required technologies.
• I have deep technical leadership managing successful delivery of all technical aspects of Epic implementations - Infrastructure fulley redundant architecture, build out of servers (MS and Linux), SAN storage, MS SQL and Cache Databases), virtualization (Citrix and VMWare), Epic foundation solutions, Epic bridges/Cloverleaf HL7 interfaces. Managed full HW deployments including end user devices (PCs, Wyse terminals, printers, scanners, credit card machines, Epic status/trackboards, etc.).
• Led the management and oversight of the Epic technical team and the application team including developing, communicating and managing the Epic environments. As part of the delivery of Epic technical readiness I have managed/coordinated architects, DBAs, Epic analysts, interface analysts, network analysts, server engineers, Citrix and VMWare engineers, InfoSec and Epic security analysts, data center managers, HW deployment/TDR Techs, Facilities PM, and network/Telecomm managers.
• Led the management of resolving complex large technical integration issues (custom development integrating with Epic), set up timelines, following up on progress that Epic analysts and technical teams have made to ensure solutions are established in a timely manner coordinated appropriate resources to manage issues. Contributed to management reporting requirements/ticket aging reporting within ServiceNow and used the tool for effective management and resolution of over 12,000 tickets originating from the first two weeks post go live. Worked with ServiceNow Admin to develop automated workflows for replacement of end user devices.

Confidential

Senior Program/Project Manager

Responsibilities:

• Led the Epic Spring 2012 Upgrade (from Fall 2010) Enterprise Planning, and Implementation. Led Cutover/Activation planning/execution. Worked with Clinical Champions (20+), clinical SMEs (15-20) and IS teams (100+, 10 work streams) to agree scope, delivery timeline, and frame the project for (500+bed) pediatric hospital. Team had to review over 20,000 Epic 2012 Upgrade release notes (essential, FYI, and optimizations) in the Epic Nova system to determine scope. Epic modules that had changes include: ADT, ASAP, Beacon, Cadence, Chart tracking, Coding and Abstraction, Deficiency tracking, EpicCare ambulatory, EpicCare Inpatient, Identity, OpTime, Phoenix, Prelude, Radiant, Referrals, Release of Information, HB/PB Resolute, and Willow Inpatient.Effort includes all interfaces (e.g. Epic Bridges, eGate, Insystems, and inbound/outbound interfaces for downstream systems) and 40+ downstream systems.
• Led the developmentof the $23M 8300+ user enterprise EPIC 2010 Acute EHR implementation plan in collaboration with hospital Clinical & IS CXO level and functional area management that was used to successfully implement the following modules Radiology (Radiant), Pharmacy (Willow), Oncology/Hematology (Beacon), Emergency Department/Bed Management (ASAP) and Orders/ClinDoc while assuring minimal clinical downtime during yearly hospital peak demand period. Developed and incorporated implementation plans for 38 downstream systems and decommissioning plans for six legacy systems.Worked with technical teams to analyze, design, modify, and test enterprise architecture components (e.g. Bridges/Tibco eGate interfaces/data bus, downstream systems interfaces, infrastructure build out, etc.), necessary to deploy the Epic application.
• Led the design, development, and implementation of three EPIC enterprise downtime technology solutions (SRO, BCA Web, BCA PC) that provide downtime reports during a downtime. Developed computer based tutorial for training clinicians on new downtime processes and solutions. Led the development and delivery of three current/future state Clinical & IS EPIC downtime processes, an enterprise clinical patient care downtime procedure, 86 departmental downtime procedures, and a monthly planned maintenanceservice level agreement.Developed Business Impact Assessments, business continuity, and disaster recovery plans (including priority of system restoration phases) for Critical Clinical and Operational systems with Application Owners, Business Owners and infrastructure. Participated in DR desktop exercises to walk through/refine DR plans.
• Led the development and execution of an Epic Acute post Implementation IS survey/focus sessions with 8300+ users and 500+ IT resourcesand developed/presented Lessons Learned recommendations for IS enterprise process improvements.
• Led the design and implementation/integration of 3M HDMS Coding and Abstracting Management solution with the Epic Health Information Management HIM Coding & Abstracting module as part of Epic 2010 Fall Upgrade. Led the requirements, design, and implementation of the Epic HIM modules (Release of Information, Coding & Abstracting, and Deficiency Tracking)and M*Modal Dictation Transcription in Nov. 2012. Developed new interfaces (Epic Bridges, eGate, and 3M interface) between Epic and 3M.
• Led the development and implementation of Epic (ADT/Prelude (registration), Cadence (scheduling), Resolute HB & PB (Billing), Radiant (Radiology)) systems at primary and specialty care (7 specialties, 10 Ancillaries) sites for ~150 Users. Led Cutover/Activation planning/execution. Developed model for rolling out future primary and specialty care sites.
• Led the requirements, design, and implementation of Metrics Dashboard that provides Epic ((ADT/Prelude (registration), Cadence (scheduling), Resolute HB & PB (Billing), Summary and detail data across Patient Access and Revenue Cycle/Billing functions.
• Led, Designed, Implemented, and Launched Epic Online Bill Pay capability for Patients to pay via MC, Visa, Amex, and eCheck.
• Led the planning phase for the develop of an integrated Business Objects universe report capability for developing Clinical Research Proposals and Grants Management Reporting by End Users. Led the development and implementation of an enterprise BI/DWH self service analytics tool called QlikView. Developed metrics dashboards for patient access and revenue cycle metrics.
• Contributed to the development of the ICD-9 to ICD-10 project planning phase governance structure at The Confidential ’s Hospital of Philadelphia (Healthcare System) during the planning phase of a multi-year program to comply with the regulatory mandate. Participated in the surveying of all HL7 CPOE and ADT interfaces across several disparate coding,diagnostic and EHR systems to identify diagnosis and inpatient procedure code traffic.Evaluated CHOP current state assessment documentation / recommendations and provided input to the program structure required for the enterprise program management plan deliverable.

Confidential

Project Manager

Responsibilities:

• Developed Project Plan Activities, Deliverables, and Schedule for Global Enterprise Implementation of Microsoft SharePoint MOSS 2007collaboration platform and phased Legacy Migrationof 130+ WSS 3.0 and Lotus Notes sites and enhancements.
• Developed Installation and Operational Qualification for Microsoft SharePoint MOSS 2007 Installation, Configuration, and Custom Components deployment including Records Center, and 21 CFR Part 11 Electronic Records/Signature Functionalityon multi-environment SharePoint server farm with MOSS Technical Architect and Applications/Infrastructure Systems Administration resource.Contributed to Design Specification.
• Worked with QA and Compliance SMEs to Determine/Define Approach to ensuring Required SDLC Validation Deliverables for GMP Enterprise System. (Requirements, Design Specification, Risk Assessment, IOQ, Requirements Traceability Matrix, etc.)

Confidential

Senior Program/Portfolio/Project Manager

Responsibilities:

• Program Managed the Strategic Definition and Architectural Roadmap to plan enablement of operational use of Adaptive Clinical Trial Designs for trial portfolio. Contributor to Six Sigma future state process analysis using DMAIC model. Led RFI/RFP evaluation and selection of vendor solutions.
• Led strategic definition of management operational and analytics dashboard prototype with Sponsor for visibility and course correction decisions relative to adaptive trial study design execution.
• Project managed the requirements definition and design for patient allocation and drug supply schedule generation system to support adaptive trial designs.
• Led RFP for evaluation and selection of Modeling and Simulation solutions for adaptive trial design planning.
• Program Managed the Strategic Definition and Five Year Architectural Roadmap to plan enablement of Global Clinical Study Portfolio Management. This included an evaluation of CTMS tools including Siebel eClinical CTMS (ultimately selected).
• Project Managed an Electronic Data Capture EDC COTS Solution Evaluation for early stage trials including Proof of concept and Selection.
• Led the definition, evaluation, selection, and implementation of an EDC Standards Library Management Solution.
• Program/Project managed the definition of operational metrics reporting & analysis for clinical trial management systems using Cognos BI/Dashboard tools.
• Project managed the definition of a Protocol Deviations & Protocol Violators Patient Alerts system for determining and resolving root cause drug study deviations at investigational sites.
• Program managed the Design and Implementation of a standard process for loading external third party global EMR and insurance claims databases into Oracle to optimize clinical development statistical analysis using SAS for the Biostatistics, Epidemiology, and Drug Safety/Pharmacovigilance groups. Assisted business in identifying and automating recurring dataset needs to support clinical trial planning and execution analysis. Explored analytic tools for feasibility; Spotfire, Cognos, etc. This system will form the basis of a 5 year Safety Surveillance analysis, detection, and monitoring strategy at Merck.
• Developed and implemented IT PMO Program and Project Level hierarchical structure of Collaborative Program and Project Team Sites in MS SharePoint 2007. Developed Project plans with enterprise resources and published to MS Project Server for integrated project status reporting. Contributed process and communication development for the global IT PMO.
• Managed Portfolio Budgets and Resources using Budget Forecasting Tools, MS Project Portfolio Server 2007, and Unanet. Managed $2.2M in IT spend for 2008. Managing $2.8M in IT spend for 2009.

Confidential

Senior Project Manager

Responsibilities:

• Managed project planning and implementation of system enhancements, infrastructure upgrades, and SDLC validation of a PDMA audit and investigation management system that receives dispersed sample totals by field sales representative from the sample management system (Sample Guardian) and uses this information to monitor and report drug sample reconciliation exceptions to the FDA in compliance with the Prescription Drug Marketing Act PDMA.
• Led the Discovery Phase to evaluate and select/recommend (via RFI/RFP using Verticalnet esourcing (similar to Ariba eSourcing Suite. This web based procurement application managed legal vendor agreements such as: NDA's, MSA, SOW, vendor contracts using process workflows as well as vendor financial proposals)) a global enterprise physical records management solution (ECM) that implements retention and destruction policies in compliance with national and international record retention regulations and supports Legal eDiscovery activities.
• Led assessment of client's records management requirements and developed a formalized ‘future state’ strategy, criteria, processes, and solution to align capabilities with senior records management's overall short and long term business goals.
• Managed enhancements to an enterprise emergency notification system and upgrade planning for a global Disaster Recovery DR/Business Continuity Planning BCP system LDRPS.Performed impact assessments per DR planning procedures to determine criticality and aligned prioritization of enterprise applications. Developed business continuity, disaster recovery and contingency plans for execution to provide continuity of critical processes during the recovery of IS systemsin the event of disasters that disable IS systems. Developed governing documents and SOP instructions on how management and operations should respond in a downtime outage situation. Participated in annual BCP and DR mock exercises.
• Managed the implementation of global enterprise visitor management system supporting all corporate sites, lobbies, and docks.
• Developed validation SDLC deliverables for deployment of Safety Surveillance System used for the collection, evaluation, review, distribution, and submission of adverse events to regulatory agencies involving products for human use.

Confidential

Senior Project Manager

Responsibilities:

• Managed project planning and implementation for Clinical IT Systems Audit Inspection Readiness for CR&D Clinical IS Applications used to set-up and deliver clinical trial results as part of the Drug Development submission process in Research and Development. Represented Clinical IS in responding to and managing audit CAPA requests for management controls around SOPs and policies, GXP Systems Validation Documentation, IT Governance processes, and Change Control.
• Developed a GCP compliant best practice software testing process and work instructions for functional OQ Testing. Formally trained 110 users on the process across applications development, testing, and support functional groups. 
• Managed multi-discipline stakeholders in the business, quality, and IT to define the approach and requirements for Response Adaptive Clinical Trials Process for Pilot Clinical Study Trial that will reduce phase II cycle time by 20%.

Confidential

Global Project Manager

Responsibilities:

• Managed program level project planning, actions/issues/risks, resource pools, global resource and budget allocations, and change management within the Confidential R&D Clinical PMO for Global Roll-out of a Clinical Web-Based Data Capture solution (Medidata RAVE) through the use of enterprise portfolio management solutions (MS EPM 2007 & Matrix Clinical Project Management System). EClinical is a group of enabling solutions that capture Clinical Trial Data from global investigational sites and CROs and manages data through to regulatory agency drug submission. www. Confidential .com.

Confidential

Senior Project Manager

Responsibilities:

• Managed application definition and IS Compliance for enhancements to a Global Clinical Trial web-based Remote Data Capture Application that Provides Clinical Trial Data to Oracle Clinical from global investigational sites and CROs through to regulatory agency submission within Confidential Pharmaceutical. This FDA regulated 21 CFR part 11 GCP Validated system is based on Java development, BEA Web Logic middleware, and Oracle database technologies. Participated in internal regulatory audit and management review of the system.
• Developed portfolio of clinical systems for determination of criticality and opportunities for removing redundancies.
• Developed IT Service Management (ITIL) best practice based services level agreement SLA for the Remote Data Capture Application between Clinical Research and Development (CR&D) and Confidential IS Shared Services.
• Developed methodology and deliverables, conducted training, and coached and mentored clinical system end users, systems analysts, and application developers on systems life cycle, project management, and GXP validation methodologies. Developed analysis and contributed to the harmonization of Research divisional level SOPs. Provided formal audit response and managed CAPA remediation of Clinical Systems audit findings by Global Compliance Auditing ( Confidential ).
• Led R&D Information Systems proof-of-concept for selection and implementation of a 21 CFR Part 11 compliant Excel Wrapper Solution CyberLab Data Management Solution for NuGenesis laboratory information management system LIMS to manage data from external lab vendors.
• Planned, developed, designed, and implemented Disaster Recovery and Restoration procedures and processes for Global Oracle Clinical databases and associated infrastructure in a regulated environment.
• Participated in OQ validation testing execution for Documentum ECMS version 5.3 upgrade.