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Kristen Smith Location
Boston, MA, US
Kristen Smith Work
Director Clinical Operations Quality @ (May 2025 - Present)
Director Clinical Quality Assurance @ (January 2023 - March 2025)
Associate Director, Operational Excellence @ (October 2019 - January 2023)
Associate Director, Operational Planning and Supply @ (March 2019 - October 2019)
Senior Manager, Operational Planning and Supply @ (March 2017 - March 2019)
Manager, Supply Chain @ (July 2015 - March 2017)
WCEA Accreditation Co-Chair @ (January 2014 - January 2015)
Librarian @ (January 2012 - January 2015)
Supervisor, Logistics @ (January 2010 - January 2012)
Specialist, Logistics @ (January 2008 - January 2010)
Customer Service Representative, Distribution @ (January 2006 - January 2008)
Kristen Smith Education
Boston University Metropolitan College
Graduate Certificate in Project Management (Project Management)
2017-2018
San José State University
Masters (Library & Information Sciences)
2008-2011
San Diego State University
BA (History)
2002-2006
Kristen Smith Skills
Archives
Cataloging
Change Control
Change Management
Clinical Supplies
Clinical Systems Implementation
Clinical Trial Management System (CTMS)
Clinical Trials
Collection Development
Computer System Validation
Corrective and Preventive Action (CAPA)
Cross-functional Team Leadership
Customer Service
Database Design
Deviation Management
Digitization
Direct-to-Patient Distribution
Electronic Data Capture (EDC)
Good Clinical Practice (GCP)
Good Manufacturing Practice (GMP)
GxP
GxP
IRT
Information Literacy
Inspection Management
Inspection Preparation
Interactive Response Technology (IRT)
Interactive Voice Response (IVR)
Inventory Management
Invoicing
KPI Dashboards
Library
Library Instruction
Library Science
Logistics
Logistics Management
Metadata
Microsoft Power BI
Oncology Clinical Research
Operational Excellence
People Management
Pharmaceutical Industry
Process Excellence
Process Mapping
Product Launch
Project Management
Quality Assurance
Quality Auditing
Quality Management System (QMS)
Rare Diseases
Research
Risk Assessment
Risk Management
Six Sigma Green Belt
Smartsheet
Staff Development
Standard Operating Procedure (SOP)
Tableau
Training
Transportation Planning
Trial Master File (TMF)
Vendor Management
Kristen Smith Summary
Kristen Smith, based in Boston, MA, US, is currently a Director Clinical Operations Quality at Candel Therapeutics. Kristen Smith brings experience from previous roles at ALX Oncology and Ultragenyx Pharmaceutical Inc.. Kristen Smith holds a 2017 - 2018 Graduate Certificate in Project Management in Project Management @ Boston University Metropolitan College. With a robust skill set that includes Archives, Cataloging, Change Control, Change Management, Clinical Supplies and more. Kristen Smith has 2 emails and 4 mobile phone numbers on RocketReach.
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