Profile Details

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USD 80 /hr

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Hire Nicole R.

United States

USD 80 /hr

Expert Project Manager Consultant in Clinical Research

Profile Summary

Motivated, customer-focused Project Manager within the Cardiovascular, Metabolic and Critical Care Department who has more than 16 years of experience in the clinical research and pharmaceutical industry. Her depth of experience is in managing clinical trials that consist of all phase I, II, III, and IV, registry, non-interventional and device trials. Ms. Rose has experience in the implementation of study protocols including grant and protocol development, feasibility, site selection and activation, patient enrollment, clinical monitoring, DSMB management, and quality close-out activities across North America and Europe. Ms. Rose holds a bachelor’s degree in Psychology with a minor in Chemistry from La Roche College.

Subject Matter Expertise

• ☆ Drug Discovery
• ☆ High Throughput Screening (HTS)
• ☆ Hit-to-Lead & Lead Optimization
• ☆ Drug Development
• ☆ Preclinical Research
• ☆ Vaccine Development
• ☆ Pharmaceutical Manufacturing
• ☆ Pharmaceutical Process Development
• ☆ Bioprocess Development
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Medical Device Safety Testing
• ☆ Wearable Technology
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Neurology
• ☆ Epilepsy & Seizures
• ☆ Movement Disorders
• ☆ Parkinson's Disease
• ☆ Alzheimer's Disease
• ☆ Ophthalmology
• ☆ Neuro-Ophthalmology
• ☆ Precision Medicine
• ☆ E-Health & Telemedicine
• ☆ Regulatory Affairs
• ☆ Pharmaceutical Management

Services

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation

Research Feasibility Study, Fact Checking, Scientific and Technical Research, Secondary Data Collection

Consulting Healthcare Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting

Work Experience

Associate Director Project Manager

Syneos Health (Previously INCResearch)

April 2022 - Present

Clinical Project Manager

PPD, Inc

February 2021 - August 2022

Sr. Project Manager

Bionical Emas

January 2021 - April 2022

Clinical Project Manager

ZOLL Medical

April 2016 - February 2021

Clinical Project Manager

University of Pittsburgh

January 2005 - February 2016

Education

Bachelor of Arts

La Roche College

June 1998 - December 2005

Certifications

• Project Management

  Brainbench

  January 2023 - Present