James Wardle Email and Phone Number

Global Director, Clinical Project Management and PMOMember of the Senior Leadership Team (SLT) reporting to the SVP of Clinical Trials and International Operations. Responsible for a Global Clinical Project Management team, approx. 130 staff members in US and UK. Also responsible for the global Program Management Office (PMO) and Business Process Improvement (BPI) function for Clinical Trials and International Operations. The PMO leads all major projects and programs for the Clinical Trials line of business, including delivery new IT systems and business process improvement projects. The Business Process Improvement function, built on a foundation of Lean Six Sigma, is focused on delivering process improvement, operating efficiencies, and meeting cost savings targets in all areas of Clinical Trials.Senior Leadership Team member responsible for leading the global Clinical Trials line of business, establishing and communicating the vision and multi-year strategic plan, and leading annual operating plan development and achievement of key strategic objectives.Lead the improve Portfolio Management Process for the Clinical Trials line of business. Develop appropriate governance structures to ensure all approved programs and projects are in alignment with the strategic direction of the organization.Transformed the methods for project management, project prioritization and approval, and project budget management.Accountable for development and reporting of key business metrics for monthly, quarterly, and annual operating plan reviews.Responsible for financial management and stewardship focused on achieving global financial targets.Responsible for line of business global restructuring initiatives aligned with strategic objectives

Provide program management and project leadership for a large clinical outsourcing initiative at a major Pharmaceutical company in Northern New Jersey.

Services function, directed IT portfolio management and the delivery of business solutions for Merck's Shared Business Services (SBS) organization. Developed strong business relationships with senior leadership in SBS, including alignment of IT objectives with SBS strategies. Delivered a leveragable set of systems (incl. workflow, integrations, and document management) for Merck's first global shared business service, to seven European countries for regional procurement activities.Delivered IT solutions, services, and audit reports for HR Shared Services, including the 2007 and 2008 SOX compliance remediation related to US Payroll and US Time and Labor.Led the implementation of an IT Portfolio governance process for Shared Business Services. Provided management of the portfolio, and acquisition of funding and resources for the approved IT initiatives. Developed the business case for implementation of a Global "Hire to Retire" (HR) shared serviceAchieved Six Sigma Greenbelt certification through a Systems Simplification initiative that resulted in an immediate annualized savings of $300K.Provided support for HR Labor Relations by delivering IT solutions to comply with new union labor contracts.Established SLA's for HR Shared Services systems, including Peoplesoft Payroll and Time and Labor. Staffed and supervised a team of business analysts and project managers for delivery of business solutions.

As a Director and Account Manager within the Global Services function, responsible for the delivery of enabling IT Systems and Busness Process Improvements for Shared Business Services (SBS). SBS is a global function responsible for standardized operations within HR, Source to Settle (procurement), Finance, and other key transactional business functions.

Program Director accountable for the successful implementation of global infrastructure initiatives, including a global migration of 50,000 desktops to Windows XP.

Director of a program management function, therapeutically aligned with Clinical Research, accountable for delivery of data collection/review/analysis solutions in support of global clincal trials.

Directed a 31 person organization responsible for the delivery of enterprise systems and services to our business clients. Managed a $9M budget and, as a member of the organizational leadership team, directed the broader 220 person ESS organization. Key business clients included HR, HR Shared Services, Procurement, Finance, Public Affairs, and Corporate Audit.Directed the 2004 global SOX compliance initiative for the IT organization.Delivered, in 2005, a new Peoplesoft U.S. Payroll System for HR Shared ServicesEnsured the successful delivery of a Peoplesoft HR Human Capital Management system and associated Payroll system for Merck's Japanese subsidiary (Banyu). Partnered with the Banyu (Japan) PeopleSoft Review Board, a senior decision-making, cross-functional team responsible for providing oversight and governance to the Banyu PeopleSoft and Payroll project team(s)Developed and introduced, as leadership core team member, a strategic sourcing initiative for IT shared services, including RFP development and vendor evaluation and selection.Provided management support for the delivery of multiple business systems and support projects for ESS clients, including HR Shared Services, HR COE's, Corporate Finance, Procurement, and Public Affairs.Created the highly successful "Raising the Bar" employee reward and recognition program for ESS.

At the request of the CIO, developed a complete business case for the development and delivery of a standard global desktop based on Windows XP for 42,000 Merck users. Developed and gained approval for the business case from the Merck Project Approval Committee, a senior cross-divisional executive team led by the CIO and the organizational VP's, and successfully delivered the program 6 Months ahead of schedule.Defined and organized a global, cross-divisional project team. Negotiated for all project timelines, deliverables, and resources across all Merck divisions geographic regions.Directed the program core team and sub-teams to ensure all program deliverables were met within agreed upon timelines and budget.Delivered Program Stage Reviews to the executive sponsors as required Provided monthly program updates to the global IT Leadership Team, communicating program status, budget, key risks and decisions requests.

Developed and directed a Program Management Office (PMO) comprised of 14 Program Managers, each accountable to a specific clinical therapeutic area for technology deliverables to enable the clinical drug programs. As a senior leader in Clinical Information Services, managed the organization's budget of approximately $40MM.Developed senior level relationships within Clinical Research and supporting groups to ensure complete understanding and alignment with key business processes, initiatives, deliverables, and timelines.Managed all IT planning/management for the VIGOR study; a large, global clinical outcomes study, including evaluation, selection, and integration of a Contract Research Organization (CRO). Received VIGOR Key Contributor award from Clinical Research for my contributions.Forged productive senior level relationships with key service provider groups in Research Information Services (RIS) and Global Information Services (IS). Clearly articulated business deliverables to these groups, and ensured the necessary technical resources were allocated to support business objectives.As a Clinical Information Services Leadership Team (CISLT) member, made key organizational decisions including those related to staffing, organizational design, and process improvement.Represented Clinical Information Services on two key clinical business teams:Continuous Improvement Team - Cycle time reduction in the clinical development process.Clinical Trial System Task Force - Chartered by senior management to examine and recommend improvements to business processes and job roles related to critical path activities.

Planned, organized, staffed and directed a 35 person global IT team to ensure the delivery of enabling data systems required for the successful completion of the VIOXX Phase 3 clinical program.Managed the on-time delivery of the required IT systems to 34 countries, across three regions.Rapidly integrated with the business to enable translation of business requirements and timelines into specific technology deliverables.Developed a rapid prototyping approach for development of clinical data collection systems. This new approach ensured all data collection systems would be available for the business milestone of "FPI" (First Patient In).Worked extensively with key service provider groups, including Corporate IS to ensure business timelines and priorities were well understood and all necessary technology was available to support this clinical program. Received VIOXX Key Contributor award from Clinical Research.

Reengineered Merck's global data network, delivering a state of the art design and implementation

As part of several industry aligned sales teams, accountable for developing client presentations, providing relevant product knowledge, designs, and general client services in support of our sales and marketing efforts. Primary areas of expertise were large data systems and software, and data networking.