Project Manager Clinical Research

PROFESSIONAL SUMMARY

Dynamic Information Technology (IT) Leader with a proven record in the pharmaceutical industry. Expertise in IT Strategy, Project and Portfolio Management, Business Process Engineering, Organizational Change Management, Relationship and Vendor Management, and ServiceNow.

PROFESSIONAL ACHIEVEMENTS

ICON CLINICAL RESEARCH, Blue Bell, PA Mar 2011 – Nov 2024

IT Global Business Systems Director

Led the IT delivery of clinical operations integrations with external pharmaceutical companies for a global clinical research organization. Collaborated closely with HR and the Clinical Learning and Development team to enhance operational efficiency and training initiatives.

Engaged with pharmaceutical business leaders and IT to develop integrations between clinical trial applications and data warehouse platforms, achieving a 99.9% successful delivery rate of nightly study information to sponsors.

Led the successful IT implementation of Workday, the HR application for all employees at ICON, completing the project within one year and adhering to the budget.

Collaborated with Clinical Operations and Project Management teams to successfully deliver multiple productivity projects, including a new electronic Trial Master File (eTMF) and study start-up applications, all completed on time and within budget.

Partnered with IT Operations to design ServiceNow workflows that enabled clinical operations and IT to effectively capture service requests related to issues with the operational interface exchanging information with the sponsor.

Spearheaded the initiative to replace the ICON legacy CTMS application with Siebel; although the year-long project did not culminate in the replacement due to the costs associated with the new application, it successfully led to enhancements in the existing clinical operational business processes.

Developed a strategy to enhance clinical trial and learning management processes, resulting in increased productivity and reduced study start-up cycle time, with the majority of the proposals successfully implemented by the business.

SXC / HEALTH BUSINESS SOLUTIONS, Warrington, PA Apr 2009 – Mar 2011

IT Director, Product Development

Directed the product development organization in the design and implementation of a new pharmacy management system, significantly enhancing competitiveness against major chain pharmacy competitors.

Re-engineered the product development lifecycle, enhanced configuration management practices, optimized productivity tracking, and refined release planning processes.

Successfully led the offshoring of development to an Indian partner, achieving a 50% reduction in development costs.

Successfully managed a team of 30 professionals, providing support to over 1,500 pharmacies across the United States and Puerto Rico.

MERCK & COMPANY, West Point, PA Mar 2001 – Nov 2008

IT Director, Client Services, US Commercial Operations

Successfully led multiple concurrent strategic initiatives to implement a new commercial business model across Brand Marketing, Sales Operations, and the newly established Customer Marketing divisions.

Collaborated with senior management to optimize the allocation of $1.5 billion in promotional assets by developing and implementing a comprehensive strategy, streamlining business processes, and integrating systems. This effort leveraged Siebel’s CRM platform, Documentum, and North Plains Digital Asset Management to effectively align Finance, Brand, and Customer Marketing functions.

Spearheaded IT initiatives within a cross-functional team to develop a comprehensive business case, establish realization measures, and redesign Marketing Resource Management processes. Utilized Lean Six Sigma and Conner Partners Change Execution Management methodologies to enhance process design and implement robust tracking metrics.

IT Director, Global Quality and Regulatory Manufacturing Systems, Merck & Company, West Point, PA

Directed a portfolio of applications and services, overseeing a team of 50 professionals and managing a budget of $15 million. Collaborated with senior Quality and Regulatory management to deliver effective business solutions, streamline IT expenditures, and prioritize operational needs across 20 manufacturing sites globally.

Managed the organizational redesign of the central IT organization to enhance cost-effectiveness and IT solution delivery for a manufacturing organization, employing Conner Partners Change Execution techniques to successfully transition 150 IT professionals, achieving a 15% reduction in overhead costs amounting to $4.5M.

Represented the Manufacturing IT department on a global initiative to design and implement a new IT operating model and methodology, initiating the transformation of Merck’s IT organization into a process-based entity aimed at enhancing business value and reducing IT costs.

Led the development of a standardized set of IT quality processes for managing global application operations and established the first IT Compliance Board to oversee Good Manufacturing Practice (GMP) applications.

Chosen by senior management to serve as the manufacturing IT Lead for Merck's first enterprise-wide global IT offshoring initiative, which achieved significant success and resulted in the team receiving a Special Achievement award from the CIO.

Successfully outsourced approximately $150 million in IT expenditures, resulting in projected savings of 15-20%.

Directed the efforts as IT Lead for the CFR Part 11 Program Management Office initiative, which had a budget of $30 million over four years. This initiative successfully remediated over 900 high-risk instruments and applications across all Merck Manufacturing sites, fulfilling the division's commitment to the FDA's Part 11 regulations.

PREVIOUS PROFESSIONAL EXPERIENCE

IT Manager, Global Quality and Regulatory Manufacturing Systems, Merck & Company, West Point, PA

Positions within IT Infrastructure and US Commercial Operations, Merck & Company, West Point PA

EDUCATION

MBA Business and Strategic Management, Temple Fox School of Business, Philadelphia, PA

B.S. Computer Science, Gwynedd Mercy College, Gwynedd Valley, PA

PROFESSIONAL CERTIFICATIONS

Certified Project Management Professional (PMP), PMI Institute Philadelphia PA

Certified Six Sigma Greenbelt, Merck & Co. West Point PA

Certified Business Operations, University College, Dublin, Ireland

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