Project Manager Medical
Resume:
Chika Shuto
Aliso Viejo, CA, USA
**********@*****.***
Summary
Certified CRA, Licensed HCP, Medical R&D scientist and project manager with recent experience in medical device and biotech industries, as well as clinical and pre-clinical trials. Expertise in clinical research, R&D management, science, operations and regulatory.
Adaptable and approachable with exceptional interpersonal relationship skills and perseverance who focuses on key corporate goals. Track record of award-winning contributions, performance-based promotions, and expanding scientific responsibilities. Diversity of backgrounds, including R&D scientist, project manager, medical researcher, financial consultant, business developer, and medical doctor.
Professional Accomplishments
ST JUDE MEDICAL, INC. Irvine, CA 2011-2016
Staff Scientist & Project Manager --- Research and Development
Conducted medical and technology researches and studies to support R&D development. Provided quality information, feedback and input to leaderships. Ability to assimilate technical and scientific information efficiently.
Responsible for pre-clinical study and clinical study by creating study plans, protocols, methods, and study reports. Conducted post-market clinical research. Knowledge of Good Clinical Practices (GCP). Certified CRA. Experienced with clinical research strategy, design, management, analytics, and quality systems. Provided technical advice and trainings in US and OUS.
Set vision and strategy for programs, managed multiple projects toward positive results, met/exceeded project timelines, achieved results under competing priorities, changing/urgent deadlines, limited resources. Adaptable, team player, great communicator, approachable, good spirited, and focused on key corporate goals.
Work cross-functionally to support US/OUS regulatory submissions in order to gain product approvals and support post-market product researches.
Track record of award winning contributions, performance based promotions and expanded scientific responsibilities. Led a team to win a semifinal award in the company technology competition.
As project manager, created each project strategy business plan, milestone deliverable timeline. Coordinated and managed multiple projects among management groups, engineer teams, KOL’s and marketing groups. Hosted project review meetings, performed new technologies demo.
Accomplished presenter, writer and published author in the medical conference meetings and medical professional journals.
Financial control and budget management with trained SAP skill.
Strong knowledge of Microsoft Office Suite programs including advanced Excel functionality, MS Project, Outlook, Word and PowerPoint, statistics analysis skill. Strong overall systems strengths desired as well.
ST JUDE MEDICAL, INC. Irvine, CA 2009-2011
Scientist Research and Development
Provided pre-clinical and clinical research skill by developing study strategies, plans, proposals and protocols; participating, performing and monitoring the studies, conducting statistics analysis and estimating the study results, evaluating overall study and filing study reports.
Worked closely with investigators, experts and physicians to develop new clinical researches. Experienced in working with global sites.
Supported the development process by executing laboratory research and performance evaluation tests to prove technical feasibility, including but not limited to perform tissue dissections and other wet lab testing, designed and created test platforms for bench tests. Documented and reported research data, summarized and presented data, analytical methods and results.
Acupuncture & Eastern Medical Center, Lake Forest, CA 2006 - 2009
Founder and California Licensed Medical Healthcare Provider --- Pain management
Managed private clinic and office and provided therapies and treatment for patients. Defined pain and other disease mechanisms. Dealt with insurance company for patients as medical provider.
Treated patients with western medical examination skills, using electrode stimulation devices and traditional oriental methods. Successfully performed over thousands treatments.
Asahi Intecc Co. Ltd. Newport Beach, CA 2005 – 2006
Coordinator---Administration
Coordinated management of the office and organized various medical catheters for sales and distribution. Provided administration skills to co-workers.
Additional Related Experience
TOKYO UNIVERSITY OF JAPAN, Tokyo, Japan
Research Fellow, Clinical Research: Collaborated with pharmaceutical companies, conducted research with biotech method and cell culture to find new treatments for cancer and immune dysfunction treatments.
SHANGHAI SEAMAN’S HOSPITAL, Shanghai, China
Physician, licensed MD
Education
Doctorate Degree, South Baylo University, Anaheim, California
Graduate School, University of Tokyo, Tokyo, Japan
Bachelor Degree, Shanghai University of TCM, Shanghai, China
Addendum
PUBLICATIONS
Effect of magnetic fields on production of peripheral blood mononuclear cell. The 41st Annual Meeting of Japan Society of Aerospace and Environmental Medicine, Abstract presentation, P16
Remodeling of Cardiac Sympathetic Re-innervation with Thoracic Spinal Cord Stimulation Improves Left Ventricular Function in a Porcine Model of Heart. ESC. Doi:10.1093/europace/euu409
Thoracic Spinal Cord Stimulation Improves Cardiac Contractile Function and Myocardial Oxygen Consumption in a Porcine Model of Ischemic Heart Failure. jce_2230 doi: 10.1111/j.1540-8167.2011.02230.x
Effects of Thoracic Spinal Cord Stimulation for Left Ventricular Remodeling in Heart Failure Insight from a Porcine Model of Ischemic Heart Failure. International Neuropsychological Society poster, 2013
Remodeling of Cardiac Sympathetic Innervation with Bilateral Thoracic Spinal Cord Stimulation Improves Left Ventricular Function in a Porcine Model of Ischemic Cardiomyopathy. European Society of Cardiology Congress 2014
Intermittent Versus Continuous Thoracic Spinal Cord Stimulation for Treatment of Ischemic Heart Failure. European Society of Cardiology Congress 2012
Thoracic Spinal Cord Stimulation Improves Cardiac Contractile Function and Myocardial Oxygen Consumption in a Porcine Model of Ischemic Heart Failure. 8 DEC 2011
DOI: 10.1111/j.1540-8167.2011.02230.x
Effects of Thoracic Burst Mode of Spinal Cord Stimulation for Left Ventricular Remodeling in Heart Failure- Insight from a Porcine Model of Ischemic Heart Failure. APHRS 2014, CardioRhythm 2015, Oral presentation.
A Porcine Model of Heart Failure with Preserved Ejection Fraction Induced by Sustained Severe
Hypertension. American Heart Association 2015, scientific sessions.
Thoracic Spinal Cord Stimulation for Heart Failure as a Restorative Treatment (SCS HEART study): First-in-man Experience. Heart Rhythm 2015;12:588-595
Regional Heterogeneity on Norepinephrine Spillover in Hypertension: Insight from a Porcine Model of Hypertension. American Heart Association 2015, scientific sessions.
Regional heterogeneity on norepinephrine spillover in heart failure with preserved ejection fraction: insight from a porcine model of severe hypertension. ESC CONGRESS 2016.
Conformal Wireless Interfaces for Neuromodulation. Nature Communications 2016
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