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Work Background
BioNTech SEProject Manager and Technical Consultant
Nov. 2022 - Oct. 2024Mainz, Rhineland-Palatinate, GermanyTechnology Project Manager and Business Analyst supporting the Digital, Data and Informatics team within BioNTech. Acted as business analyst and assistant project manager for the implementation of a clinical data repository utilizing the eClinical elluminate platform. Performed day-to-day project management activities including vendor management as well as assisting the business with process and requirements definition. Responsible for review of all vendor system and validation documentation. Responsible for coordination and verification of business testing activities. Project Manager and Business Analyst for the implementation of nQuery sample size calculation tool and Pinnacle 21 Enterprise data package validation tool for the Biostatistics group. Responsible for all validation documentation and testing activities.
Merck KGaA, Darmstadt, GermanyProject Manager and Technical Consultant
Mar. 2017 - Oct. 2022Darmstadt, Hesse, GermanyBusiness Technology Project Manager and Business Analyst on the OTTO & Company Strategy Consultants team supporting the analysis and implementation phases for a Global Grant Management System including Investigator Sponsored Studies and Medical Education Grants. Performed day-to-day project management activities including vendor and financial management as well as assisting the business with process and requirements definition. Responsible for development and review of system validation documentation and testing activities.
Shire Pharmaceuticals LLCProject Manager
Feb. 2015 - Dec. 2016Lexington, Massachusetts, United StatesClinical Technology Project Manager supporting operational and project change requests for clinical systems including Oracle Siebel Clinical Trial Management System and SAS Drug Development. Performed day-to-day project management activities as well as development of business cases for project review and approval. Managed Shire and vendor teams for a large SAS Drug Development upgrade to SAS Life Science Analytics Framework.
Quintiles Transnational CorpTechnical Consultant
Aug. 2013 - Nov. 2014Raleigh, North Carolina, United StatesMember of the PVST Project Team and Business Workstream for client implementation of Global Argus Safety System. Responsible for leadership and direction of business workstream along with management of cross functional activities. Participated in project planning and overall business activities in addition to providing subject matter expertise for cross functional activities and issues. Assisted with program and project management activities including resource allocation, schedule updates, status reports, and executive updates. Provided coordination and leadership to Japan team working on implementation of system for Japan.
Millenium PharmaceuticalsProject Manager and Validation Lead
Sep. 2009 - Jul. 2013Cambridge, Massachusetts, United StatesMember of the Strategic Project Management Office for the Millennium Medical Informatics, Strategy, and Operations group. Responsible for performing project management, validation lead tasks, and business analysis for the on-going maintenance of the clinical trial management system. Responsible for managing the vendor team and coordinating with the QA and training groups. Co-project manager and validation lead for the implementation and validation of a clinical trial management system. Responsible for the day-to-day management of project activities including weekly project team meetings, project plan and schedule updates, and status reporting. Responsible for the coordination and management of validation activities including the authoring, review, and approval of validation documentation, acting as liaison to the QA group, and working with the business users and vendors to ensure completion of validation tasks. Technical team member for integration, data migration, and business process re-engineering sub-teams.
ePharmaSolutionsProject Manager
Jan. 2009 - Mar. 2009Conshohocken, Pennsylvania, United StatesProject manager for the ePS/CRIX International program. Assisted with development of the overall program governance, scope, and team structure. Responsible for developing the over program project plan and schedule. Responsible for managing the day-to-day activities of the ePS IT team along with coordinating with the development team. Responsible for the project documentation including SOPs, document templates, validation, installation, and test plans, requirements and design specifications, and installation and test scripts.
PfizerProject Manager and Technical Consultant
Oct. 2008 - Aug. 2009New York, United StatesTechnical project manager for the implementation and pilot of a web-based spontaneous adverse event reporting system (ASTER). Responsible for the installation and testing of system components and acting as liaison to the hosting partner. Responsible for managing development efforts with the development partner. Responsible for the management and development of project documentation.
CRIX InternationalProject Manager
Feb. 2008 - Dec. 2008Reston, Virginia, United StatesProject manager for the implementation of the CRIX Portal. Responsible for coordinating with the hosting partners and managing the validation effort for the initial implementation and ongoing upgrades to the CRIX Portal. Responsible for managing development efforts with the various development partners. Worked with the CRIX Product Manager and Executive Director to develop timelines and scope for platform initiatives. Responsible for the management and development of project documentation. Responsible for the user/organization administration of the CRIX Portal and coordination of technical pilots with sponsor organizations.
BiogenProject Manager and Technical Consultant
Oct. 2006 - Nov. 2007Cambridge, Massachusetts, United StatesProject manager for the upgrade of the SAS application suite. Responsible for managing the day-to-day activities of the technical project team and coordinating efforts between the IT and business teams. Responsible for the review of all validation documentation as well as project status reporting and team meetings. Worked with the IT and SAS consulting staff to help ensure successful installation and configuration of the system. Project manager and technical consultant for the implementation of a new clinical data imaging system (CRFTrack) with an interface to the Oracle Clinical clinical data management system. Responsible for managing the day-to-day activities of the technical project team and coordinating efforts between the IT and business teams. Responsible for the creation and review of validation documentation, execution of validation test scripts, and resolution of technical issues. Worked with the IT and Image Solutions consulting staff to help ensure successful installation and configuration of the system.
BiogenProject Manager
Aug. 2005 - Feb. 2006Cambridge, Massachusetts, United StatesProject manager and technical consultant for the implementation of a new clinical data management system (Oracle Clinical). Responsible for managing the day-to-day activities of the technical project team and coordinating efforts between the IT and business teams. Took over responsibility for the validation effort after a change in scope and resources; including creation and review of validation documentation, execution of validation test scripts, and resolution of technical issues. Worked with the IT and Oracle consulting staff to help ensure successful installation and configuration of the system.
MassLightSoftware Development Consultant
Feb. 2004 - Aug. 2004Washington, District of Columbia, United StatesWebObjects application developer supporting the Defense Technical Information Center (DTIC). Responsible for the development, deployment, and maintenance of various intranet applications supporting government and military personnel. Responsible for client interaction and requirements analysis. Development on Windows NT using WebObjects, Java, Oracle and LDAP services. Deployment on MACOSXServer platform.
MassLightConsultant
Sep. 2000 - Mar. 2001Washington, District of Columbia, United StatesTechnical lead and project manager for WebObjects development project. Responsible for the development, deployment, and maintenance of an intranet application that allowed school systems to track educational progress of children with disabilities. Responsible for client interaction and project scheduling. Development on Windows NT using WebObjects, Java, OpenBase and ReportMill. Deployment on MACOSXServer platform.
Galt AssociatesTechnical Consultant
Sep. 1999 - Oct. 2006Sterling, Virginia, United StatesSystems Architect/Consultant for the Technology Services division of Galt Associates/Cerner Galt. Provided technical leadership and mentoring to other members of the Technology Services group. Assisted senior management with technical scope and proposal development for system integration and custom development projects. Acted as project manager, lead technical engineer, and customer liaison for numerous integration and system implementation projects. Responsible for the analysis, design, implementation, and validation of the integration of Galt’s medical coding dictionary web application, dsNavigator (ASP, C++, VB application), with the clinical and safety applications (Clintrial, Oracle Clinical, SAS SDD, Clintrace, ARISg, Argus, Oracle AERS) used by Galt’s clients in the pharmaceutical and bio-tech industry. All integrations were custom and accomplished through various technical implementations of dsNavigatorDXS along with database procedures, application programming interfaces (HTML and/or C++), and/or new system development. Extensive experience with validation activities including authoring of validation documents (validation plans, IQ/OQ/PQ protocols and scripts, traceability matrices, summary reports), execution of scripts, and production cutover activities. Responsible for development and project documentation including requirements specifications, design specifications, test procedures, validation scripts, system SOPs, and user manuals for system implementation projects including:
• Clintrace customizations in support of new European regulatory requirements
• Implementation of Argus safety system
• Custom KPI Signaling reporting application for Argus safety system
Calicode, Inc.Owner
Feb. 1999Provide high-level IT consulting to the pharmaceutical industry for implementation of clinical and safety systems. Primarily responsible for the project management and implementation of system validation efforts.
Apple ComputerProfessional Services Manager, Senior Consulting Engineer
Sep. 1996 - Sep. 1999Reston, Virginia, United StatesMember of the AES Southeast/Federal Consulting Management Team, responsible for directing consulting services and client support of Web-based and E-Commerce initiatives. Direct responsibilities included project management, technical leadership, and software development of numerous government projects generating over $1M in annual revenue. Day-to-day project management duties included contract management, account and financial management, project scheduling, status reporting and resource management. Provided technical management of Apple and non-Apple development team members. Additional roles included acting as lead technical architect and senior developer. Acted as lead project liaison to the ISPs providing the application hosting services. Applications were written using the Apple WebObjects and EOF technologies, Objective-C, Java, NetCharts, and Oracle. Development was done on Windows NT with deployment on Solaris. Projects included:
• An electronic contract/solicitation posting management system (Electronic Posting System – EPS) which was adopted by the Federal Government as the single point of entry for all contracts
• The secure proposal/bid submittal system enhancement to the EPS
• A financial project management system for the GSA Public Building Services Division Senior consultant on numerous projects covering client-server and Web-based application development. Provided clients with analysis, design, development, test, and deployment expertise for applications using the Apple OpenStep, EOF, and WebObjects technologies. Provided technical leadership and mentoring to client development teams as well as to junior Apple consultants. Projects included:
• A software development project graphical mapping tool • A newspaper classified order and layout management system • A security camera management system • A telecommunications order-entry system
Booz-Allen & HamiltonSenior Systems Engineer
Nov. 1994 - Sep. 1996Vienna, Virginia, United StatesLead developer for numerous software development and maintenance projects designed for a client’s human resources department. Applications included two data transfer tools, an electronic phone book tool, a management employee information tool, and a human resources data management tool. All applications were designed for client-server architecture using objected-oriented techniques and software (NEXTSTEP, Objective-C) and a relational database (Oracle). Assisted database team with the Oracle database design and maintenance. Interfaced with clients and other developers to complete all aspects of the software development life cycle process including requirements analysis, system and software design, code and unit test, installation and maintenance. Developed the supporting documentation, including requirement specs, design specs, and user manuals. Helped prepare for and participate in all client meetings, team meetings, formal reviews and demos. Mentored other developers and support team personnel and helped management schedule and track project tasks. Administered the development LAN consisting of NeXT and Intel machines running NEXTSTEP.
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