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プロフィール詳細
Kristen D.に依頼
United States
Seasoned Global Clinical Operations & Regulatory Affairs Medical Devices Specialist
プロフィール概要
専門分野
サービス
Writing
Clinical Trial Documentation,
Medical Writing,
Non-Medical Regulatory Writing,
Technical Writing,
Business & Legal Writing,
Creative Writing,
Audio Transcription,
General Proofreading & Editing
Research
User Research,
Feasibility Study,
Technology Scouting,
Fact Checking,
Gap Analysis,
Gray Literature Search,
Scientific and Technical Research,
Systematic Literature Review,
Secondary Data Collection
Consulting
Business Strategy Consulting,
Healthcare Consulting,
Operations Consulting,
Scientific and Technical Consulting,
Regulatory Consulting
Data & AI
Data Mining,
Data Cleaning,
Data Processing
Product Development
Material Sourcing,
Product Compliance ,
Concept Development,
Product Launch Support
職務経験
Executive Advisor
A&C Foundation
5月 2025 - 現在
Executive Advisor
A+C Foundation
5月 2025 - 現在 
VP Clinical & Regulatory
Newronika S.p.A.
4月 2023 - 10月 2024
VP Clinical & Regulatory
Newronika S.p.A.
4月 2023 - 10月 2024
Senior Clinical Director
Functional Neuromodulation
5月 2019 - 12月 2023
Senior Clinical Director
Functional Neuromodulation
5月 2019 - 12月 2023
Global Manager
Syneos Health (United States)
10月 2016 - 4月 2019
Global Manager - Clinical Operations
Syneos Health (Previously INCResearch)
10月 2016 - 4月 2019
Senior Clinical Manager
Functional Neuromodulation
3月 2012 - 10月 2016
Senior Clinical Manager
Functional Neuromodulation
1月 2012 - 10月 2016
Research Quality Improvement Specialist
Baylor University Medical Center
1月 2011 - 3月 2012
Research Quality Improvement Specialist
Baylor University Medicall Center - Baylor Research Institute
1月 2011 - 3月 2012
Global Regulatory Affairs Manager
Flextronics - Avail Medical Division
8月 2008 - 1月 2011
Corporate Global Regulatory Affairs Manager
Flextronics International
8月 2008 - 1月 2011
Director of Clinical & Regulatory Affairs
Organ Transport Systems
6月 2006 - 7月 2008
Director - Clinical & Regulatory Affairs
Organ Transport Systems
6月 2006 - 7月 2008
Clinical Program Manager
Advanced Neuromodulation Systems
4月 2004 - 5月 2006
Clinical Program Manager - Deep Brain Stimulation
Advanced Neuromodulation Systems
4月 2004 - 5月 2006
Senior Clinical Research Associate
Johnson & Johnson
2月 2003 - 4月 2004
Senior Clinical Research Associate
Crocath Technologies
1月 2001 - 2月 2003
Senior Clinical Research Associate
CryoCath Technologies
1月 2001 - 2月 2003
Global Clinical Manager
BioInterventional
8月 1999 - 1月 2001
Senior Clinical Specialist & Trainer
St. Jude Medical
9月 1997 - 8月 1999
Senior Staff Physiologist
Cleveland Clinic
7月 1993 - 9月 1997
学歴
Masters (Science)
Central Michigan University
8月 1991 - 5月 1997
Graduate Internship
University of Michigan
1月 1993 - 7月 1993
Physiology (Health Education & Sciences )
Central Michigan University
1991 - 1993
Bachelor of Science (Psychology)
Michigan State University
9月 1986 - 6月 1990
Bachelor of Science
Michigan State University
9月 1986 - 6月 1990
認定資格
-
Fundamental Neuroscience for Neuroimaging
Johns Hopkins University
https://www.coursera.org/account/accomplishments/verify/99E4QT7F56MX2月 2025 - 現在
-
Intercultural Conflict Resolution & Conflict Resolution
University of California at Irvine
https://www.coursera.org/account/accomplishments/verify/UXFFNW9U68BH2月 2025 - 現在
-
Artificial Intelligence & Human Subjects Protections
CITI
https://www.citiprogram.org/verify/?wac4aad7e-abad-4e15-90ef-34e7f395a5f7-670073161月 2025 - 12月 2025
-
Corporate Strategy
University College of London
https://www.coursera.org/account/accomplishments/verify/QW82943LPZWA1月 2025 - 1月 2025
出版物
JOURNAL ARTICLE
Jurgen Germann, Amaral RSC, Tomaszczyk J, Yamamoto K, Elias GJB, Gouveia FV, Vasilevskaya A, Taghdiri F, Devenyi GA, Sankar T, et al. (2025). Biomarker changes associated with fornix deep brain stimulation in Alzheimer's disease . Alzheimer's & dementia : the journal of the Alzheimer's Association.
Steven D. Targum, Fosdick L, Drake KE, Rosenberg PB, Burke AD, Wolk DA, Kelly Foote, Wael Asaad, Sabbagh M, Smith GS, et al. (2021). Effect of Age on Clinical Trial Outcome in Participants with Probable Alzheimer's Disease . Journal of Alzheimer's disease : JAD.
Jeannie-Marie Leoutsakos, Yan H, William Anderson, Wael Asaad, Baltuch G, Burke A, Chakravarty MM, Drake KE, Kelly Foote, Fosdick L, et al. (2018). Deep Brain Stimulation Targeting the Fornix for Mild Alzheimer Dementia (the ADvance Trial): A Two Year Follow-up Including Results of Delayed Activation . Journal of Alzheimer's disease : JAD.
Andres M. Lozano, Fosdick L, Chakravarty MM, Jeannie-Marie Leoutsakos, Munro C, Oh E, Drake KE, Lyman CH, Rosenberg PB, William Anderson, et al. (2016). A Phase II Study of Fornix Deep Brain Stimulation in Mild Alzheimer's Disease . Journal of Alzheimer's disease : JAD.
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