プロフィール詳細

プロジェクトを作成

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Eric D.に依頼

United States

A clinical operations expert with over 25 years of experience in global clinical strategy and execution.

プロフィール概要

Over 25 years of experience in all facets of clinical research including with a focus on early phase medical devices and combination products. Significant experience in the design and execution of first-in-man and feasibility trials including protocol development through final report/submission to regulatory authorities. My experience is primarily within cardiac, neurology, and vascular. Geographically I have significant experience managing trials in the United States, Canada, Europe, Israel, Australia, and Hong Kong/China including extended assignments within these regions. Through various roles within the industry, I have proven excellence in the management of clinical trials and associated regulatory interaction; therapeutic and technological expertise; and KOL development and management.

専門分野

• ☆ Decision Science
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Wearable Technology
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ Point-of-Care Devices

サービス

• Writing

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing

職務経験

Medtronic Foundation

- 現在

Founder and Lead Consultant

Anchor Point Clinical Consulting

8月 2018 - 現在

VP, Clinical Developemtn

Cerebral Therapeutics

8月 2018 - 8月 2024

Executive Director, Medical Device and Diagnostics

INC Research

5月 2016 - 8月 2024

Director, Clinical Medical Device and Diagnostics

Novella Clinical

10月 2010 - 5月 2016

Clinical Project Manager

Medtronic

2月 2006 - 10月 2010

学歴

Bachelors

St. Mary's University of Minnestoa

8月 1992 - 6月 1996

認定資格

• 認定資格の詳細は未入力です。