プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Nishita P.に依頼

Canada

Clinical Operations & Strategy Consultant | Driving Global Trial Success & Patient-Centric Innovation

プロフィール概要

I’m a Clinical Research & Strategy Consultant with over 17 years of experience leading global Phase I-III trials across oncology, hematology, infectious diseases, and rare genetic disorders. My career spans biotech, pharma, and academic settings, where I’ve successfully built high-performing teams, streamlined trial operations, and delivered innovative solutions for complex and multi-regional studies. I bring a dual focus: strategic trial execution and hands-on site management expertise. From launching an institutions first CAR-T study and optimizing feasibility for trials across 10+ countries, to developing SOPs and quality frameworks that passed FDA/EMA/Health Canada inspections, I deliver results that accelerate timelines, reduce risk, and ensure compliance. My freelance services include: - Global clinical operations: study planning, feasibility, trial execution, and risk-based monitoring (RBM) - CRO/vendor management: selection, oversight, budget alignment, and performance evaluation - Regulatory & inspection readiness: SOPs, deviation/CAPA tracking, quality oversight, audit prep - Site management support: • Regulatory document and ethics submission review • Protocol and ICF development/review • Site SOP/process development and optimization • Onboarding, training programs, and team performance coaching Whether you're a sponsor, CRO, or academic site, I bring strategic insight, operational excellence, and deep regulatory knowledge to help you deliver high-quality, patient-centric trials; on time and within budget. Let’s work together to elevate your clinical development programs.

専門分野

• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Patient Recruitment
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Oncology
• ☆ Regulatory Writing
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Technical & Scientific Writing
• ☆ SOP & Protocol Writing

サービス

• Writing
• Consulting

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, General Proofreading & Editing

Consulting Healthcare Consulting, Operations Consulting, Regulatory Consulting

職務経験

Clinical Trial Manager

Moderna TX

10月 2023 - 4月 2025

Clinical Research Manager

Princess Margaret Cancer Centre

10月 2014 - 10月 2023

学歴

MBA

University of Toronto - Rotman School of Management

10月 2021 - 6月 2023

認定資格

• Certified Clinical Research Professional

  SOCRA

  6月 2008 - 現在