
Sylvie Akiel-Fu Mph
- Over 17 years of extensive experience conducting post-market, pre-market studies approved under IDE and investigator initiated clinical... | 2187 Foxworthy Avenue, San Jose, United States
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Sylvie Akiel-Fu Mph’s Location 2187 Foxworthy Avenue, San Jose, United States
Sylvie Akiel-Fu Mph’s Expertise - Over 17 years of extensive experience conducting post-market, pre-market studies approved under IDE and investigator initiated clinical research studies in small start-up or mid-size medical device industry - Strategic planning for long term partnerships both internally and externally - Develop and manage relationships with key opinion leaders (KOLs) - Thorough knowledge and understanding of ICH/Good Clinical Practice (GCP) guidelines, 21 CFR, Good Clinical Data Management Practices (GCDMP), MEDDEV and standards proposed by Clinical Data Interchange Standards Consortium (CDISC), and extensive experience in writing standard operating procedures (SOPs) - Experience in medical device, social and oncology research in US, EU and Asia - Extensive experience in clinical operations, CRO/vendor management, budget planning and resource modeling - Extensive knowledge of statistical analysis and various software (SPSS, SAS, SYSTAT, STATA) and various database applications (MedLog, Microsoft Access, Clindex, Oracle) and Electronic Data Capture Systems and Clinical Data Management Software (KIKA Medical/Merge Healthcare, Medidata Rave and Grants Manager, Octagon Research Solutions, Fortress Medical Systems) Specialties: Experience in all stages of Clinical Trials Management from study design, protocol writing, CRF design, CRO and EDC vendor selection, site selection, budget and contract negotiations, site monitoring, SOP writing and process standardization, database design to complete data management, statistical analysis and report writing.
Sylvie Akiel-Fu Mph’s Current Industry Imperative Care
Sylvie
Akiel-Fu Mph’s Prior Industry
Columbia University Harlem Hospital
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Memorial Sloan Kettering Cancer Center
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Arthrocare
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Spinal Kinetics
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Zoll Circulation
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Intuitive Surgical
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Imperative Care
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Work Experience

Imperative Care
Director, Clinical Affairs, Imperative Care Vascular
Fri Apr 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Intuitive Surgical
Manager Clinical Affairs
Wed Aug 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Apr 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Intuitive Surgical
Sr. Clinical Project Manager, Clinical Affairs
Mon Jun 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Aug 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Zoll Circulation
Project Manager, Clinical Affairs
Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri May 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Spinal Kinetics
Clinical Research Manager
Fri Jul 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Nov 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Arthrocare
Clinical Research Associate (CRA) /Data Specialist III
Mon May 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Apr 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)
Arthrocare
Clinical Research Manager
Sun May 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Aug 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Arthrocare
CRA/Data Specialist II
Sun May 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Apr 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Memorial Sloan Kettering Cancer Center
Project Coordinator for the National Colonoscopy Study, a Multi-Center Randomized Clinical Trial
Fri Oct 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Apr 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Columbia University Harlem Hospital
Research Assistant - Harlem Adherence to Treatment Study
Tue Jan 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)