プロフィール詳細

プロジェクトを作成

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Paul H.に依頼

United States

Freelance Clinical Operations Expert with >15 years of clinical research experience / Phase I-IV international trials

プロフィール概要

Experience with all aspects of clinical trial execution, from concept / protocol writing to clinical study report writing. Have worked with a wide range of companies from small biotech startup to large multinational pharma. Multiple therapeutic areas. Registered Nurse / Critical Care ICU background. Site / CRO management. Data Management/ eCRF Development, Strategy, Protocol Execution, Cross Functional Team Leader, Regulatory, FDA, EMA, ICH/GCP, Contracts, KOL Relations, Medical Affairs, Clinical Development

専門分野

• ★ Drug Development
• ★ Clinical Trials
• ☆ Pharmaceutical Sciences
• ☆ Medical Affairs
• ☆ Regulatory Writing

サービス

• Writing
• Research
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Gray Literature Search, Systematic Literature Review

Data & AI Statistical Analysis

職務経験

Associate Director Clinical Operations / Global Trial Leader

Johnson & Johnson / Janssen

6月 2017 - 現在

Associate Director Clinical Operations

Actelion Pharmaceuticals US, Inc

6月 2014 - 6月 2017

Associate Director Clinical Operations

Cerexa Inc / Forest Labs

7月 2012 - 5月 2014

Clinical Project Leader - Pharmaceutical Consultant

Genentech / Roche

6月 2010 - 6月 2012

Director Clinical Operations - Consultant

Cangene

6月 2009 - 5月 2010

Sr. Clinical Research Manager

Cardiome Pharma Inc

12月 2003 - 5月 2009

学歴

Bachelor of Science in Nursing (BSN) RN

Belmont University

8月 1999 - 12月 2001

Associate of Science in Nursing (ASN) RN

Regents College

8月 1988 - 12月 1991

認定資格

• 認定資格の詳細は未入力です。