Over eighteen years of experience within the pharmaceutical industry with strengths in IT project management, business analysis, clinical operations, and quality documentation:
➢ Experienced Technology Project Manager within the pharmaceutical industry: In-depth knowledge in IT project planning & execution, software quality and validation, and software engineering, with a specialty in the areas of EDC, CTMS, clinical data management, patient recruitment, regulatory publishing, document management and knowledge management within pharmaceuticals
➢ Highly-capable Manager & Team Leader, responsible for leading teams of software developers, testers, trainers, support and operations personnel, motivating, mentoring, and training staff to achieve success
➢ Well-rounded background, working in the technology field as a software engineer, requirements analyst, programmer, validation specialist, SOP writer, process consultant, trainer, among other roles
➢ Innovative technology professional developing and supporting solutions within the pharmaceutical, insurance, and financial service industries. Background also includes designing, programming, and testing systems; contracting IT software and services; creating standards and SOPs; recruiting and mentoring IT talent; supporting business development; and supporting corporate senior management in strategic planning
Clinical Quality Management Consultant @ Within the Quality and Continuous Improvement and Technology & Information Mgmt Teams:
➢ Worked with Q&CI resources to project manage and support authoring of Clinical SOPs for Monitoring, including Risk-Based Monitoring, Source Data Verification and Review, Site Selection and Recruitment, CTMS setup and maintenance, IVRS setup and maintenance.
➢ Collaborated with process engineering team on Clinical process mapping initiative.
➢ Managed TIM project to build a centralized reporting portal for the Clinical and Medical teams.
➢ Provided expert advice on Risk-Based Monitoring and SDV/SDR module in RAVE. From June 2014 to Present (1 year 7 months) Operations Manager: CTMS @ Within the Global Monitoring Operations group at FRI: implemented, configured, and led operational improvements of the Medidata CTMS:
➢ Managed an operational support team with three direct reports, supporting the CTMS operations.
➢ Managed a cross-functional team to support CTMS training, improvement, and operations, working with Medidata to configure the CTMS and develop custom extensions and reports.
➢ Collaborated with teams on issues, refinements, service management, and communications
➢ Participated in drafting the Clinical SOPs and process maps for protocol deviations, CRO operations, investigator safety letters.
➢ Involved in process improvement initiatives for Risk-Based Monitoring, streamlined study start-up, and contact management. From October 2011 to June 2014 (2 years 9 months) IT Project Manager @ Within the PMO of the Research Informatics group at FRI, worked as a project manager on new systems, upgrades, strategic and process improvement initiatives:
➢ Project Manager on multiple IT projects, including the implementation of the Oracle/PF Coding System, EZsubs Publishing System, the selection of the Doublebridge Pyramid Archival solution, among others. Ensured that the right solution was delivered within defined scope, budget and time
➢ Ensured quality deployment as the Validation Lead for multiple workstreams during the first installation and subsequent upgrades of the Oracle/PF Inform EDC System at FRI
➢ Participated in all SDLC phases of project delivery
➢ Played a key contribution towards the improvement of best practices for the PMO From September 2003 to October 2011 (8 years 2 months) Sr. Validation Specialist @ ➢ Responsible for the validation of software systems used in manufacturing
➢ Authored validation policy documents jointly with Global CSV From October 2002 to September 2003 (1 year) IT Consultant @ ➢ Manager for 8 developers and support analysts on the QCER team at GlaxoSmithKline, responsible for building electronic review tools to support quality review of CSRs
➢ Software Engineer providing consulting, programming, and sales support for ITM's eForms and PDFinFusion products
➢ Programmer/Analyst for the ESARC Publishing Group at GlaxoSmithKline, supporting submission development From February 1996 to August 2002 (6 years 7 months)
MS, Computer Science @ Villanova University From 1997 to 2001 BA, English @ Ursinus College From 1988 to 1992 PMP certification @ PMI Jeffrey Smith is skilled in: FDA, Computer System Validation, SDLC, Requirements Analysis, Software Project Management, Project Portfolio Management, Programming, Software Training, Training & Development, System Testing, Agile Project Management, Agile Methodologies, Clinical Trials, Clinical Data Management, Patient Recruitment