Saki N.
Clinical Research Associate
Experience
Oct 2020 - May 2024
3 years 8 monthsJapan
Clinical Research Associate
Parexel International, Osaka office
- Supported global Phase II/III clinical trials in COPD and Crohn’s disease, coordinating with medical institutions and pharmaceutical sponsors.
- Supported clinical trials, including site selection, initiation, and progress management, to evaluate the efficacy and safety of new drugs or treatments.
- Prepared and managed essential trial documents (study reports, monitoring reports) in Japanese and English, ensuring compliance with relevant regulations.
- Collaborated with pharmaceutical companies and medical institutions, assisting in the translation and localization of trial materials for effective information sharing.
- Coordinated between domestic and international stakeholders and Japanese sites to support clear communication for clinical trial operations.
Mar 2020 - Present
5 years 8 monthsJapan
Medical Writer
Freelance
- Collaborated with multiple clients to create and edit clinical trial–related documents in compliance with regulatory standards.
- Engaged in AI model training projects requiring Japanese content.
May 2018 - Oct 2018
6 monthsJapan
Practical Training for Pharmacist
Takasago Seibu Hospital and Harima Pharmacy
Summary
Worked as a Clinical Research Associate where I managed clinical trials for approximately four years.
Currently, I work freelance as a medical writer.
Languages
Japanese
NativeEnglish
AdvancedChinese
AdvancedEducation
Apr 2014 - Mar 2020
Kobe Pharmaceutical University
Bachelor of Pharmacy · Pharmacy · Kobe, Japan
King’s College London
Master of Drug Development Science · Drug Development Science · United Kingdom
Certifications & licenses
Pharmacist license
Japan
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