プロフィール詳細

プロジェクトを作成

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Nisha N.に依頼

Australia

Clinical Research Professional with More Than A Decade Of Industry Experience (CRO, Site, And Academic Set-Up)

プロフィール概要

• Experienced Clinical research professional, with the strong academic foundation of Graduation in Pharmacy and Post-graduation in Biochemical Pharmacology. • Worked in the full spectrum of Clinical Research Project life cycle, having a sound understanding of Clinical Research Concepts, Strong technical knowledge of ICH GCP, ISO 14155, ISO 9001, ISO 13485, ISO 14971, NHMRC etc., Local and International Regulatory Guidelines. • Experienced in Project Management and Business Development at CRO level, and at Site Level. • Experienced in creating a comprehensive Quality Management System (QMS) for an upcoming Clinical Research Organization (CRO). • Registered Member of ARCS and ACRP.

専門分野

• ★ Clinical Trials
• ★ Healthcare Communications
• ★ SOP & Protocol Writing
• ☆ Drug Development
• ☆ Bioavailability
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Safety Testing
• ☆ Medical Implants
• ☆ IRB Applications
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Regulatory Affairs
• ☆ Hypothesis
• ☆ Regulatory Writing
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Patient Education Materials
• ☆ Research Summaries & Abstracts
• ☆ Technical & Scientific Writing
• ☆ Case Studies
• ☆ Science Communication

サービス

• Writing
• Research
• Consulting

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

Research Feasibility Study, Scientific and Technical Research

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

職務経験

Founder, Director

Leorah Clinical Pty Ltd, Australia

11月 2021 - 現在

Clinical Operations and Quality Management Consultant, Australia

Self employed

7月 2021 - 現在

Clinical Project Manager

CMAX- a division of IDT, Australia

5月 2013 - 4月 2014

Clinical Research Coordinator

International Musculoskeletal Research Institute (IMRI), Australia

11月 2009 - 4月 2013

lecturer

Indian Institute of Clinical Research (ICRI), India

12月 2008 - 5月 2009

Clinical Monitoring Manager

Synchron Research Pvt Ltd, India

3月 2007 - 12月 2008

Site Relation Specialist, Site Management Services

IQVIA (India)

11月 2005 - 1月 2007

学歴

Master of Science: Biochemical Pharmacology

University of Southampton, United Kingdom.

10月 2003 - 11月 2004

Bachelor's in Pharmacy

Rajiv Gandhi University of Health Sciences, India.

10月 1998 - 11月 2002

認定資格

• FUNDAMENTALS OF DIGITAL MARKETING

  Google

  1月 2021 - 現在

• Vegan Nutrition Health Coach

  Mystic core movements LLC (through Udemy)

  7月 2020 - 現在