Suzanne Spiker, PMP
Senior Project Manager at CALYX- Claim this Profile
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English Full professional proficiency
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French Native or bilingual proficiency
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Bio
Experience
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CALYX
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Project Manager
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Jan 2021 - Present
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Parexel
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Project Manager
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Jan 2019 - Present
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PPT Consulting | a Sia Partners Company
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United States
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Business Consulting and Services
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1 - 100 Employee
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Senior Project Manager
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Oct 2014 - Oct 2018
Clinical Trial Management System Integration - managing internal and external resources, budget, schedule, risks across 4 worktreams (Configuration, Data Migration, Data Reporting, Datafeeds) Successfully completed 3 M&A integrations of R&D systems and data across Clinical, Regulatory, GMA, PV and Non Clinical Clinical Trial Management System Integration - managing internal and external resources, budget, schedule, risks across 4 worktreams (Configuration, Data Migration, Data Reporting, Datafeeds) Successfully completed 3 M&A integrations of R&D systems and data across Clinical, Regulatory, GMA, PV and Non Clinical
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Project Manager
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2011 - 2013
Managed Data Migration, Data Reporting and Aggregation workstreams of a validated Laboratory Information Management System (LIMS) from a legacy system to a Commercial off The Shelf system with a team of internal and offshore resources within budget allocated.
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Program Manager
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2010 - 2011
Portfolio management of IT small to medium greenfield projects. Accountable for evaluation and selection of projects, successful execution and maintenance of Small Applications Portfolio for R&D using Agile methodology.- TEAM LEADERSHIP: Provided Leadership, Vision and Direction to team of FTE's and offshore technical leads and developers. Direct line management of FTE's. Managed performance and career development in line with HR policies/practices. Mentored and developed employees which lead to their advancement within the company.- PROJECT EXECUTION: Ensured projects goals and objectives were achieved within agreed time, cost, scope and quality parameters.- DELIVERY & MAINTENANCE: Triage, delivery, maintenance and decommissioning of 100+ non validated R&D applications including externally facing web sites to quickly address business needs and provide tactical solutions to R&D Discovery, Pre Clinical, Clinical, Biopharm, Finance, Legal, HR and IT.
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Rapid Delivery Team Leader
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2005 - 2009
Managed a project group that created software using Agile and Rapid development models for R&D Clinical. Duties included Portfolio Management (evaluation/selection of project requests, development effort and support)RESOURCE ALLOCATION & MANAGEMENT: Line managed team of FTE's located in Philadelphia, NC, London and identified, engaged, managed offshore resources located in India, which led to significant savings for the company.PROJECTS DELIVERY AND MAINTENANCE QUALITY PLANS: Delivered projects in line with IQMS (Integrated Quality Management System). Provided stakeholders documented processes and activities to produce quality deliverables which adhered to delivery and support standards.
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Project Manager
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2001 - 2005
Delivered software development projects to R&D clients. Duties included managing resources responsible for the development of applications using a variety of development tools, creating and maintaining documentation and working with Computer Validation and Compliance to determine level of validation needed as well as transitioning applications to Support.
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Principal Document System Analyst
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1997 - 2001
Provided technical support of a regulated Document Management system based on Documentum.- managed system maintenance.- provided second level client support.-performed system administration duties including routine maintenance, access control, system monitoring, troubleshooting, problem resolution and incident reports for Test, Training and Production environments
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University of Pennsylvania
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United States
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Higher Education
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700 & Above Employee
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System's Analyst
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1986 - 1991
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Education
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Université de Montréal
Baccalauréat ès Sciences, Computer Science -
University of Pennsylvania
Independent Study & Internship