George Lewis
Senior Project Manager @ Thermo Fisher Scientific
About
Seasoned Senior Project Manager with 7+ years of experience driving cross-functional initiatives (clinical, regulatory, CMC) through the drug development phases. Adept at leveraging AI-enhanced project management tools to boost project efficiency. Expertise includes a can-do perspective, stakeholder negotiations, scenario planning, Integrated Project Plans (IPP), risk mitigation, timeline oversight, vendor/CRO oversight, recognized Financial Stewardship accomplishments, and associate coaching sessions. Dynamic leader, strategic-thinker dedicated to accomplishing organizational goals, fostering a culture of communication, accountability amongst cross-functional team leaders, and highlighting associates for senior leadership visibility. Known for translating strategic priorities into lead delivery plans, acquiring $354M of new business, business continuity improvements, and operational excellence.
United States
Loganville
Pharmaceuticals
Advertising, Strategic Partnerships, Business Development, Complex Project Management, Strategic Project Management, Project Leadership, Clinical Trial Management System (CTMS), Regulatory Submissions, Clinical Trial Support (Phase I-IV), Study Set-Up, Study & Site Monitoring, Data Management, Program Support, Compliance Monitoring, Project Coordination, Vendor Management, Statistical Data Analysis, Project Management, Risk Management, Protocol
Experience

Senior Project Manager
Wilmington, NC, USA
SENIOR PROJECT MANAGER Jun 2022 - Jun 2025 ThermoFisher Scientific Wilmington, NC, USA • Cultivated diverse functional teams, improving communication, resulting in expedited issue resolution. • Pioneered the adoption of the Financial Stewardship Support Initiative, reducing project overruns by 60% and saving the organization $12M annually through early issue identification and mitigation. • Spearheaded cross-functional leadership, ensuring delivery of project milestones while enhancing stakeholder collaboration and elevating client satisfaction 10% in 18 months. • Mentored and developed a team of eleven project managers in the Financial Stewardship Support Initiative, implemented a skills matrix, and personalized development plans that resulted in a 36% increase in internal promotions. • Partnered with Clinical Operations to strategically develop project plans, goals, and regions, gaining consensus and cooperation. • Effectively summarized key information such as project/program progress, timeline updates, and risk /opportunity assessments for periodic presentations to senior leadership. • Oversaw vendor RFPs (Request for Proposals) and provided oversight of milestone deliverables. • Implemented risk management strategies that effectively mitigated delays, ensuring seamless project progression. • Analyzed performance metrics to identify process and system optimization opportunities, improving study execution efficiency. • Matured partnerships with stakeholders and pharmaceutical investors through driving business development initiatives that opened new organizational growth channels, resulting in $354 M of new business.
Project Manager
North Wales, Pennsylvania, United States
• Successfully managed study activities across five projects with a +90% early or timely completion rate. • Developed project plans, which elevated team performance metrics 32% through planning precision. • Maintained precise budget records and reconciled vendor costs, ensuring financial accuracy while adhering to project timelines. • Coordinated global teams and vendors overseeing equipment planning, ensuring timely site deliveries, and upholding forecasted project schedules.
Global Clinical Trial Manager
North Wales, Pennsylvania, United States
• Spearheaded project milestone deliverable timeline tracking with enhanced stakeholder engagement through improved deliverable visibility and risk management. • Implemented structured project management methodologies to ensure the timely and early completion of milestones during emerging regional and global crises, thereby enhancing stakeholder trust. • Managed project budget of $2M, optimizing resource allocation and reducing financial waste by 7%. • Analyzed trial performance metrics to identify bottlenecks and implement targeted strategies, leading to 19% gain in study efficiency.

Project Manager (1099)
Corementum
Irvine, California, United States
• Managed the pharmaceutical adaptation and rollout of customized Veeva Vault Platform across 3 organizations, training 300+ end-users and achieving a 98% adoption rate within 4 months, leading to a 20% increase in sales productivity. • Optimized project resource allocation using predictive analytics, resulting in a 25% reduction in project overruns and a 15% improvement in team utilization rates. • Facilitated workshops to define system configuration, governance, and operational expectations. • Cultivated a culture of core team and client engagement, promoting team building, knowledge sharing, and improved collaboration, which improved productivity and client program satisfaction.

Sr. TMF Process Analyst / Sr. Business Analyst (1099)
Corementum
Irvine, CA
• Owned TMF operational process customizations and implementations for Veeva Vault, ensuring compliant documentation, audit readiness, and lifecycle traceability. • Developed SOPs and artifact guidelines for TMF artifact filing, ensuring compliance, accuracy, smoother audits, and improving inspection results. • Guided stakeholders on TMF structure, metadata models, and inspection-readiness best practices. • Streamline TMF process workflows, improving artifact tracking across organizations.

Project Manager
Edison, NJ
• Orchestrated the seamless integration of 2 acquired companies into the organization's project management framework, standardizing methodologies, and tools across 200+ team members, leading to a 40% increase in cross-functional collaboration. • Led a cross-functional team of 27+ professionals in delivering a cloud migration project 3 months ahead of schedule, resulting in $5M in cost savings and a 99.99% uptime improvement for critical business applications. • Analyzed performance metrics to identify process and system optimization opportunities, improving execution efficiency. • Pioneered the development of an interactive dashboard, enriching data transparency, and client engagement in trial monitoring.

Clinical Trial Associate
Cary, North Carolina, United States
• Facilitated collaboration among team members, encouraging open communication and shared accountability for programing outcomes. • Maintained comprehensive data management processes while repurposing data systems, ensuring accuracy and customized client technical requirement standards programing to ensure on-time system delivery. • Implemented a new advertisement and screened patient to site distribution database, resulting in 25% site patient enrollment rate improvement. • Spearheaded database management efforts, achieving timely system updates and migration milestones, which significantly increased stakeholder satisfaction.

Regulatory Compliance Manager
Atlanta, GA
• Analyzed regulatory frameworks to streamline compliance strategies, resulting in more effective navigation of complex submissions and improved I.R.B. study approval timelines. • Orchestrated site, C.R.O. (Contract Research Organization), and pharmacy teams’ alignment to project delivery goals, fostering a culture of collaboration that improved project delivery timelines and patient outcomes. • Implemented a regulatory submission tracking system which significantly improved submission quality and enabled adjustments to regulatory strategies. • Mentored team members on regulatory best practices, enhancing their skillsets, and contributed to a supportive learning environment. • Optimized regulatory submission processes, enhancing compliance, efficiency, and minimizing I.R.B. (Institutional Review Board) approval delays, leading to smoother clinical project execution.

Clinical Project Manager
Quintiles
Details are available if requested.

Clinical Project Support Specialist
Quintiles
Details are available if requested.

Clinical Research Associate
ClinProxy
Details are available if requested.

Senior Clinical Trial Associate
ClinProxy
Details are available if requested.
George Lewis's Contact Information
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