Profile Details

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USD 40 /hr

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Hire Priyanka W.

India

USD 40 /hr

Clinical Research professional with 15+ years of experience in Clinical Project, people and quality management

Profile Summary

Experience in following: - Clinical Operations: Clinical Monitoring, Therapeutic Areas, Clinical Trial technologies, QMS Management - People Management: Staffing and Resource Management, Mentoring, Training development plan, Team building - Business Strategy & Process Improvement: Creating Business strategy and Growth Roadmap, Rebranding, Change Management, Risk Management, SOP writing, review, and improvement. - Data Analytics: Operational Trend analytics, Competitive data analytics for resources, Utilization analytics - Project Management: PMP® Member, PMBOK® 7th Edition Trained, EDGE Tool, Trending analysis.

Subject Matter Expertise

• ☆ Knowledge Management
• ☆ Pharmacy
• ☆ Clinical Pharmacy
• ☆ Drug Development
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Oncology
• ☆ Chemotherapy
• ☆ Healthcare Administration & Management
• ☆ Healthcare Quality Improvement
• ☆ Regulatory Affairs
• ☆ Immunotherapy
• ☆ Gene Therapy
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Peer Review
• ☆ Research Methodology
• ☆ Feasibility Studies
• ☆ Gap Analysis
• ☆ Instructional Webinars
• ☆ Skills Training
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing
• ☆ Course Content Writing

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, General Proofreading & Editing

Research Market Research, Feasibility Study, Fact Checking, Gap Analysis, Scientific and Technical Research

Consulting Business Strategy Consulting, Operations Consulting

Data & AI Data Visualization

Product Development Quality Assurance & Control (QA/QC)

Work Experience

Manager

Fortrea

September 2019 - December 2023

Clinical Trial Manager

ICON, Plc

September 2015 - August 2019

Senior Clinical Research Associate

Quintiles

November 2008 - July 2015

Clinical trial assistant

Amgen

April 2008 - November 2008

Education

Bachelors in Science( biology)

Purdue University

January 2002 - May 2006

Certifications

• Post graduate diploma in Clinical Trial management

  Bilcare Institute, Pune

  April 2008 - Present

• ACRP certification for Clinical Research Professional

  ACRP

  April 2007 - April 2008