SUMMARY:

• 18+ years of experience in leading enterprise and systems analysis, architecture design, project management, systems engineering and business to business customer implementations in technology and service - delivery areas.
• Clinical Research IT experience, including Clinical Trials Systems design and deployment, FDA regulatory data, and Biomedical Imaging.
• Experience leading multiple complex capital projects within teh health care industry in accordance with domestic and international GxP regulations.
• Extensive experience in business and systems analysis, with strengths in understanding customer business objectives and legacy application systems. Career success in rebuilding business processes and setting up cost effective and efficient solutions.
• Experience with CRM and e-business technology solutions including analytics and reporting.
• In-depth understanding and experience in ITIL and business process modeling including experience with end user support integrations.
• Experience managing multiple projects and customer engagements using Project Management tools and processes.

TECHNICAL SKILLS:

Languages: Java, JSP, C++, Visual Basic, PL/SQL, XML, HTML

Platforms: IBM-PC/Pentium, Macintosh, IBM Mainframe, DEC-VAX

Operating Systems: Windows 2000/2003, Windows XP, Vista, Linux, HP-UNIX, SUN Solaris

Software Packages: Crystal Reports, VBScript, Dynamics, Informatica PowerCenter, SharePoint 2010, ERwin Data Modeler, EMC Documetum, SAP Business Objects, JD Edwards

Tools / Utilities: MS Project, MS Project Server, MS Exchange Server, Microsoft Office, Visio, Rational Rose Enterprise, ERwin Data Modeler, Visual Studio 2008, ARISg

Web: BEA WebLogic, SilverStream Web Server, Microsoft IIS, ColdFusion, ASP .NET

Standards: HL7, DICOM, ITIL

Databases: ORACLE 9i, Sybase, Microsoft SQL Server, VAX/RDBMS, MS-Access

Network: TCP/IP, DNS, Active Directory, Cisco IOS, Firewall, Data Encryption, SAN/NAS

PROFESSIONAL EXPERIENCE:

Confidential, PA

Project Manager

Responsibilities:

• Maintained responsibility for teh planning, design and delivery of IT solutions for Field Inventory Management System across Trauma, CMF and Spine division.
• Responsible for teh translation of business requirements and solution designs into Field Equipment application specifications within teh SharePoint solution, integrating JD Edwards’s systems.
• Collectively worked with business to analyze existing processes and identify gaps for field inventory management and supply chain landscape. This led to design and development of information services to support operational efficiency and data quality.
• Provided functional leadership to matrix project team comprising of SharePoint and JDE developers, database engineers, validation specialist and external vendors. Effectively managed resources, schedule, budget administration and quality of deliverables through teh full project life cycle.
• Oversaw and actively managed existing application support, new application development, project completion and support for SharePoint and JD Edwards applications.
• Defined and delivered project plans and communications for various levels of stakeholders - team member to senior management. This included updates to Clarity and Microsoft Project Servers.
• Facilitated resolution of risks and issues, escalating when necessary with Quality, Business and IT senior management.
• Managed deployment of applications consistent with Johnson and Johnson quality and Project Management Office standard process.

Confidential, Chesterbrook, PA

Project Manager

Responsibilities:

• Managed final deployment of SharePoint, FirstDoc and PleaseReview integration project for Research and Development. Established and managed project schedules; SharePoint, FirstDoc SPX, Docbase and PleaseReview development efforts; Validation requirements and Stakeholder expectations.
• Implementation solution included a secure collaboration interface into teh 3D (Document Management) System to support multiple business functions requiring ability to share controlled documents inside and outside teh Shire network. FirstDoc SPX leveraged document management functionality and business rules of teh 3D FirstDoc Enterprise application within a SharePoint portal.
• eReview software supported collaborative review using annotation of PDFs or native Microsoft Word collaboration functionality within teh 3D environment and deployed to business groups who require this capability, across Shire R&D. This solution automated teh manual review process without having to manually remove teh document from 3D - delivering time savings and process improvements.
• Coordinated with Shire’s infrastructure, SharePoint and external partners to plan and control teh releases to test and production environments.

Confidential, PA

Senior Project Manager

Responsibilities:

• Planned, scheduled and monitored shutdown of IMPACT (Legacy system) and migration of data to SAP for Merck Manufacturing Division (MMD), IT. Coordinated transitions of IMPACT shutdown to COMET go live with Process Leads. Implemented new SAP Services with technologies (Workflow, WMS, etc.) by following IT/SAP Project Management Methodology. Supported SAP COMET Competence Center and Program Management in project / program management tasks.
• Lead role in planning and implementation of wireless upgrade project for manufacturing and office automation. Performed project planning and ROI measurements by defining new set of business indicators to create a "score card" of existing and future operational business and IT service needs relating to Wireless Computing potential. Primary liaison between Manufacturing and Facility clients and external engineering and vendor resources in teh design, specification, procurement and commissioning of wireless automation systems for cGMP production facilities.
• Developed a Support Strategy and Support Model for Laboratory Information Management System (LIMS). Actively managed and completed all phases of assigned equipment, facilities, utilities and process qualification and validation activities for teh project. Facilitated cross functional problem solving involving Quality Assurance, Regulatory Affairs, Engineering and Manufacturing.
• Managed teh deployment of Refrigerant Compliance Manager System for MMD Environment and Safety department in compliance with Merck’s SDLC processes. This included Change Controls, Process Validation Protocols, and Process Validation Reports.
• Delivered accurate and candid communications, presentations, and escalations to senior management across teh department regarding status, needs, or gaps on active projects. Partner with business and technology teams to enhance core process and tools associated with IT Operations while ensuring process compliance with IT Governance, PMO, Regulatory and Compliance.
• Responsible for ITIL Service Transition program - support and maintenance levels including Monitoring, Change and Release Management. Managed programs and projects in MSPS portfolio while adhering to SDLC and project quality metrics established by teh PMO.

Confidential, Wilmington, DE

Project Manager

Responsibilities:

• Managed all cross functional and integration and communication touch points for teh SharePoint migration project under USIS Commercials. Established and managed project scope boundaries, credible schedules with effort-based, resourced tasks or activities with managed critical path.Partnered with Global IT Communications team on direction and overall plans for communications effecting both organizations.
• Coordinate teh execution of eRoom to SharePoint Migration Plan for USIS Commercial. This included data cleaning, status reporting to track engagements, coordination between region and central migration team and develop communication plan.
• For USIS Solutions Lifecycle division implemented ITIL process by planning and controlling teh movement of large and complicated releases to test and live environments and ensuring that teh integrity of teh live environment is protected and that teh correct components are released.
• Coordinated with teh project lead and IT partners to ensure proactive change management and communications are in place Progress reporting - define key metrics, monitor progress and forecast.
• Provided governance for all emergency and normal change and ensured release packages can be tracked, installed, verified and/or uninstalled or backed out if necessary. Work with development and infrastructure areas to ensure event plans has contingencies in place.

Confidential, Frazer, PA

Sr. Consultant

Responsibilities:

• Managed six concurrent project activities for WMRO IT&S relating to Medical Affairs, Quality, Pharmacovigilance, Clinical Data Management and Infrastructure group.
• Developed project plans, identified necessary resources, and executed project management tasks throughout teh life of a project in accordance with teh PMO. Tracked financial spending and manage budget related to teh projects. Provided timely and accurate communication of key project issues and events to senior management.
• Provided expert technical support and guidance for teh implementation of WMRO IT&S projects. Packages include SharePoint, EMC eRoom, Business Objects, TrackWise, ARISg and IRMS COTS systems.
• Worked closely with Medical Affairs, Global Pharmacovigilance (GPV) and Quality Control as well as IT Business Enablement Teams to define, plan and deliver IT solutions. Worked through all phases of solution implementation including focus groups and workshops with business partners to solicit and record requirements; testing teh implementations with quality team and finally deploying teh solutions to Medical Affairs, GPV and Commercial operations department.
• Coordinated with quality control team for integration of cross reference data with TrackWise to streamline product safety and complaint handling process.
• Involved in teh deployment of SharePoint pmPoint to track and manage multiple large projects that effect Medical Affairs, R&D, Clinical and GPE for new project requests and portfolio management.

Confidential, Colegeville, PA

Project Manager (Consultant)

Responsibilities:

• Responsible for planning, scheduling and monitoring multiple project activities for Clinical BSP relating to SDLC.
• Tracked financial spending related to teh projects as well as coordinated communication plans and steering committee meetings.
• Effectively organized resources by coordinated core team activities across multiple contributing teams ensuring tasks are done on time, within budget and support strategic direction.
• Managed PMO activities using eRoom to create project plans, tasks and milestone and collaborated group activities to improve teh development, and delivery of application.
• Assisted in teh analysis and development of Process Improvement Methods to increase throughput and efficiency of teh clinical project management team.
• Identified operating procedures by researching and evaluating existing and proposed systems. Analyzed, defined and documented business and functional requirements specifications.

Confidential, Newtown, PA

Manager, Application Development

Responsibilities:

• Confidential is a provider of Medical image management for clinical trials halping healthcare clients maximize teh statistical power of image data and obtain regulatory approval.
• Led Microsoft .Net development teams with full staffing and budgetary responsibilities. Reorganized teams establishing team charter; group and individual objectives; SDLC methodology; SLAs, and development standards. Developed project schedules and deliverables.
• Managed teh balance of production support with multiple new development and implementation projects for centralized image processing and independent review service.
• Collaborated with pharmaceutical companies such as Roche, Confidential, Bristol-Myers Squibb, Confidential, Genentech and GSK in protocol design and review, site recommendations/preparation, image processing and integration with Clinical Data for regulatory review, Managed teh analysis, development and implementation of global and third party medical imaging applications.
• Prepared software development schedules, documentation and change controls.
• Identified gaps and solutions between business processes and various applications standardizing web development platform and metrics.
• Assisted Business Development group in developing sales forecasting, planning, and budgeting process used within Bio-Imaging to proactively identify opportunities for sales process improvement and assist in understanding process bottlenecks and inconsistencies.
• Responsible for managing CRM utilized by sales department and assisted in teh development of CRM segmentation schema and business rules, reports and performance tracking across a variety of key performance metrics.
• Managed and prioritized competing business interests and cross-functional programs/projects with measurable benefit to teh business.
• Resolved project issues including budget, timeline, scope definitions and management, software functionality and technology.

Confidential, Newtown, PA

Director, Technology Services

Responsibilities:

• Lead a team of developers and project managers to analyze teh workflow and ensure teh integration of outsourcing operation efforts in India. This included frequent personal involvement—with up to 30% global travel, ensuring overseas staff are meeting or exceeding business technology requirements.
• Developed a vision that anticipates teh current and future needs of teh operation to meet or exceed architecture strategy and platform definition which includes portal technologies and data warehouse structures.
• Assisted sales to establish a budget, forecast and reports on service and pricing trends, training programs. Led Development, Functional Specialist and Solution Architectures in teh implementation of Microsoft Dynamics CRM working closely with Sales and Marketing functional areas. Built and developed technology infrastructure and analytics platform to support CRM capabilities.
• Worked with client representatives and other program teams in developing solutions that address teh people, process, and technology needs of teh organization.
• Played a lead role for development of business requirements and communication of requirements to development teams in U.S. and offshore in India.
• Implemented new operations support technologies and techniques that enable teh capabilities of teh developer staff overseas to efficiently and productively support business requirements.
• Established relationships and alliances with several web based medical image management companies for deployment of teh enterprise wide solution.

Confidential, Philadelphia, PA

Director, IT Research and Development

Responsibilities:

• Directed teh organization wide imaging production and development environments in teh areas of Enterprise Applications, Desktop Applications, Security Management, and Development/Staging of Data Center & Infrastructure.
• Analyzed clinical systems against IT and business strategies and made well-defined recommendations and execution plans for efficiency and architecture/design improvements within and outside of current projects
• Provided comprehensive consultation to business units and clinical research team at teh highest technical level on all phases of teh project development cycle.
• Designed and architected BEA's WebLogic clinical subsystems and major enhancements to existing SilverStream application using IBM Rational Rose and Oracle database.
• Supported teh collaborative relationships with universities, scientific institutions academic organizations, pharmaceuticals and governmental resources such as caBig and RSNA to support teh long range technical objectives within teh research program.
• Evaluated Industry Standards such as caBig and HL7 with knowledge of teh HL7 Reference Information Model. Performed detailed analysis of integration requirements, including HL7, DICOM, and imaging technologies.
• Participated on internal cross-functional teams to deploy Clinical Trial solutions by integrating with customer systems and third party solutions (HL7 integration, DICOM validation). Implemented Patient/Consumer Engagement Health IT related projects in collaboration with other HIMSS teams, programs and initiatives.

Director

Confidential

Responsibilities:

• Directed all aspects of Information Technology services. Provided strategic vision and direction to Technical Support Services, Applications and Database Solutions, and Configuration Controls. Ensure teh delivery of an efficient and reliable technology environment that meets or exceeds user expectations and compliance regulations.
• Provided leadership for a group of 13 internal technology staff dedicated to solution management and implementation for Therapeutic and Diagnostic Clinical product development and operational support systems with an annual operating budget of $7 million.
• Ensured completion of appropriate information security risk assessments and identified non-compliance issues. Managed teh remediation effort to address results of information security risk assessments to meet teh needs of regulatory compliance.
• Collaborated with pharmaceuticals such as Confidential and Bristol-Myers Squibb to meet regulatory compliance and to adhere to FDA and HIPAA regulations. Projects included email encryption compliance using Entrust Entelligence Messaging products.
• Provided executive leadership, along with authoring, execution and implementation of departmental policies, processes, procedures, governances and guidelines.
• Successfully managed teh production operations for a highly complex environment consisting of 4 enterprise applications, 50 Windows & UNIX servers within a 3,500 sq ft Data Center and 40 Terabytes of NAS/SAN storage.
• Responsible for corporate wide Active Directory management including design.
• Designed, configured and deployed Microsoft Exchange. Managed support of all components of Exchange architecture including Archiving and Journaling. Configured and troubleshoot email transport related technologies such as DNS, SMTP, RPC and POP3.
• Drove 5-10% year over year IT-controlled reductions through establishment of company-wide policies, improved software license management, and targeted outsourcing of services aligned with business fluctuations, focused vendor negotiations, and service-vendor management.
• Developed a structured approach to Clinical Trial Management Systems within Therapeutic and Diagnostic projects. Developed and managed a Computer Operations programs responsible for Clinical Trials data processing and related tasks. Implemented Tele Radiology and Remote Data Capture Systems for multi-center Clinical Trials.
• Integrated Sybase PowerDesigner data modeling for scalable Clinical Trial Management System. Technology centric meta-data and was fully integrated with SQL Server for role-based security on models, version control and configuration management including delta reports. This supported major development platforms such as Oracle/SQL server, Java J2EE and PowerBuilder.
• Interacted closely with X-Ray, CT, MRI, Ultrasound and PET manufacturers, to sort out DICOM validation issues.
• Implemented an adaptive System Development Life Cycle (SDLC) for faster delivery of application and database development efforts.
• Project management and chief architect responsibilities for all applications and staff. Recommended improvements in teh areas of messaging, database management and application performance. Manage and maintain enterprise level Microsoft SQL database and Exchange Servers.
• Implemented appropriate procedures to protect teh network, support secure access controls and connectivity. This included development and implementation of security procedures and protocols governing network operations.
• Conducted threat and vulnerability assessments to properly analyze teh risks to information security and determine appropriate measures to effectively manage teh risks.
• Developed new infrastructure to migrate systems from VAX/VMS to SQL environment. Managed a team of Network Engineers, Support Staff and Application developers.
• Lead teh migrations from VAX/VMS system to 100 seat, 20-server multi-domain PowerBuilder client/server architect and implemented strategies to leverage emerging enterprise technologies such as SMS, Remote Management, Enterprise NAS/SAN storage support, and Global security authentication
• Designed and maintained Network including network components and communication components for high level of reliability and flexibility. Designed and launched information network linking users and development staff to Windows services.
• Served as teh solution architect for teh definition of a data and application migration from VAX/VMS based application designed for deployment across Client/Server Model.
• Responsible for LAN and WAN configuration and design as well as maintenance of server hardware, network/power infrastructure components and product support for Microsoft server products (Exchange, SMS, and SQL Server).