Hiroko Otao has over 10 years of experience in project management and clinical research. She has managed over 40 clinical studies for conditions such as psoriasis, asthma, and COPD while working at CMIC CRO and GlaxoSmithKline. Her experience includes vendor management, budgeting, reporting, customs clearance, and translating documents between English and Japanese. She is proficient in English, Mac and PC programs, and has a B.A. in Agricultural Science from Tokyo University of Agriculture.

1. Hiroko Otao
303, 1-18-14 Omori-Kita, Ota-ku, Tokyo,
080-4056-8912, happypiroko72@hotmail.com
Summary of experience
- 2 years’ experience in Project Management at CMIC CRO, including Vendor management for 8 ICCC
projects,1 Japanese local projectand ProjectManagement for 2 ICCC projects.
- 3 years’ experience in supporting CRAs for Global Studies at GlaxoSmithKline Pharmaceutical
Company.
- 5 years’ experience with administrative Clinical Development Department staff at GlaxoSmithKline
Pharmaceutical Company.
Job Experience
Sep.2013 - Present
CMIC Co., Ltd., Tokyo
Title: Project Specialist
Took responsibility for management timelines and budget for Central laboratory;Conduct Clientaudits
for the following2nd bulletstudy as a Vendor Manager for Central laboratory:
- An In-Country Clinical Caretaker PhaseI/III study of Plaquepsoriasis,Ongoing
- 2 In-Country Clinical Caretaker Tobacco studies,completed successfully
Title: Project Specialist
Took responsibility for escalation and reportingto overseas Spiro/ECG and ePRO vendors, and training
employees at the affiliated call center for the followingstudies as a Vendor Manager Assistant:
- A Japaneselocal PhaseII study of Atopy drug, completed successfully
- An In-Country Clinical Caretaker PhaseII study of Asthma drug diseases,completed successfully
- 2 In-Country Clinical Caretaker PhaseIIb/IIIand PhaseIII studiesof Asthma drug diseases, Ongoing
- An In-Country Clinical Caretaker PhaseIII study of COPD drug diseases,Ongoing
Title: Project Assistant
Took responsibility for the followingstudies as a ProjectManager Assistantfor Central laboratory:
- An In-Country Clinical Caretaker PhaseI study of Plaquepsoriasis,Ongoing
- An In-Country Clinical Caretaker Phase II/III study of an orphan drug for pediatrics (endocrinological
disorder),Ongoing
Apr.2004 - Aug.2013
Glaxo Smith Kline K.K.,Tokyo
Title: Vendor Management, in Clinical Research Department
Managed Clinical Research Group,includingthe followingtasks:
- Negotiate with vendors to resolve procedural/supply/courier issues and report back to Central
Laboratories
- Navigate Customs Clearanceprocedures for Lab Supplies
- Liaisewith Central (UK and US) GSK Pharma for IP, and Central Labs (US, Singapore) for samples
- Translatemanuals (for Lab samplecollections,IVRS,EDC systems)

2. Hiroko Otao
303, 1-18-14 Omori-Kita,Ota-ku,Tokyo, 080-4056-8912, happypiroko72@hotmail.com
- Prepare FDA documents with ConsultantCompany in India
Title: CRA Assistant,in Clinical Research Department
Managed Clinical Research Group,includingthe followingtasks:
- Create documents for IRBs/ JapaneseMinistry of Health, Labour and Welfare.
- Prepare documents for Serious/ Adverse Event Reports
- Perform Data entry for Ledger Invoices for clinical trials
・ DiseaseIndications
40 Studies: Pulmonology,Cardiovascular,Neurological,Oncology,Immunology, etc.
Apr.2003 –Mar.2004
Orbotech Japan Co., Ltd.,Tokyo
Title: Accountant, Finance& Operations
Managed Account Payments (300 customers/ month)
Nov.2002 - Mar.2003
Sumitomo Metal Mining Co., Ltd.,Tokyo
Title: Administrativesecretary for the department, Production & Technology Department
Aug.2002 - Nov.2002
Böwe SYSTEC Japan, Ltd., Tokyo
・ Title: Accountant, Finance
Jul.1996 - Sep.2001
Yamaha Music Tokyo Co., Tokyo
・ Title: Accountant, Finance& Operations
Education
Graduation date: March 1996
Tokyo University of Agriculture, B.A. in Agricultural Science,
Faculty of Brewing and Fermentation, Tokyo, Japan
Continuous Education
December, 2003- September, 2004,
University Nevada Reno, Reno, NV
Credit earning; (via affiliated accounting school in Japan)
Financial Accounting, Managerial Accounting, Financial Reporting
September, 2001- June, 2002
Bellevue Community College, Bellevue, WA
ELS program, Comp essentials / Digital Media, Desktop Publishing,
Improving Read Skill-Lab, Basic Ceramics

3. Hiroko Otao
303, 1-18-14 Omori-Kita,Ota-ku,Tokyo, 080-4056-8912, happypiroko72@hotmail.com
Language and PC Skills
 Japanese:Native
 English:Professionalworkingproficiency (TOEICscore:825, Sep2016)
 ProficientinMacintoshandPCLiteracywith experience usingMSWord,MS
Excel,MS PowerPoint,MSAccess,OutlookandNotes.
 Familiarwithinternetandknowledge of developingWebsite(HTML/XML)
 Typingspeed;Japanese:110/min.English:90 words/min.10 key227/ min.
 BATIC;Accountantlevel(December2010)