I graduated Kyoto Institute of Technology and joined Novo Nordisk. I was in charge of Sales, Execution of Clinical trials and IP-GMP QA in Novo Nordisk. After I left Novo Nordisk in Aug 2014, I moved to Malaysia with my daughter. She is learning at International School in Malaysia. I was involved in Asian P3 Study for Cervical cancer as Clinical Project Leader from Jul 2015 to May 2016.
In private, I am a single mother from 2007 after my partner had passed away.
My father and husband have passed away young. I want to help others, especially people in troubles. I spent less time with my daughter due to busy work and business trips, which made her lonely. I hope we continue to live together.
・On-site Feasibility review for M&A project of Medical institute in Malaysia ・Project Management of Online Medical Platform for Healthcare professional in Malaysia ・AI Doctor project (preparing/editing Medical Data and Learning materials) ・Prepared English Medicine Data Set for Drug information system ・Wrote Newsletters for Patients
・Investigate overseas Start-up companies and prepare/write web contents for Media of Samurai Incubate, “SAKIGAKE” ・Be in charge of Start-up companies in Healthcare/Medical/Agriculture ・Close Media, “SAKIGAKE”, in Jul 2017
- Executed Asian Trial (Phase 3) - SDV(Source Data Verification) Visits in Malaysia and Thailand with CRAs - Gave the compliance training (including Good Documentation Practice) to Clinical Research Associates and Trial Site staff
・4 years’ experience in Investigational Products Quality Assurance (Japan) - Conducted all Batch release of Investigational products from the factories and Qualification Test of Cold Storage room - Conducted Vender Audits as a trainee Lead-Auditor - Participated GMP Audit (held by Novo Nordisk, Denmark)
・6years’ experience in clinical development as a Clinical Research Associate(CRA) / CRA Leader/Senior CRA (Japan) - Executed Global trials and Local trials (100% Enrollment) - Participated PMDA Inspections, GCP Audits
・10 months’ experience as QC for Clinical Trials (Japan) - QC check for Essential documents in Trial Master Files/Site Files
・6 years’ experience as Medical Representative (Japan) - kept over 80% Insulin Market share - Established the community consists of Specialist and GPs, held study workshops regularly