Profile Details

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Hire Paul H.

United States

USD 165 /hr

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

Profile Summary

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

Subject Matter Expertise

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

Services

• Writing
• Research
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Gray Literature Search, Systematic Literature Review

Data & AI Statistical Analysis

Work Experience

Associate Director Clinical Operations / Global Trial Leader

Johnson & Johnson / Janssen

June 2017 - Present

Associate Director Clinical Operations

Actelion Pharmaceuticals US, Inc

June 2014 - June 2017

Associate Director Clinical Operations

Cerexa Inc / Forest Labs

July 2012 - May 2014

Clinical Project Leader - Pharmaceutical Consultant

Genentech / Roche

June 2010 - June 2012

Director Clinical Operations - Consultant

Cangene

June 2009 - May 2010

Sr. Clinical Research Manager

Cardiome Pharma Inc

December 2003 - May 2009

Education

Bachelor of Science in Nursing (BSN) RN

Belmont University

August 1999 - December 2001

Associate of Science in Nursing (ASN) RN

Regents College

August 1988 - December 1991

Certifications

• Certification details not provided.