転職 : Clinical Quality Manager

職務経験

6年以上 

英語レベル

日常会話レベル 

日本語レベル

ネイティブ 

最終学歴

大学卒： 学士号 

現在のビザ

日本国籍、または日本での就労許可が必要です  

Our client, a global pharmaceutical and chemical company is seeking a Clinical Quality Manager for their Tokyo branch. The Clinical Quality Manager will be responsible for promotion and management of compliance with clinical studies GCP of drug medicine and SOP of the company in Japan.

QC work
・ Manage and operate work so that clinical studies meet the regulatory requirements such as GCP etc.
・ Initiate to avoid deviation of ongoing clinical studies after reviewing audit reports
・ Revise documents such as clinical trial protocols, study report and application documents (CTD) etc from the overall consistency point of view

SOP creation work
・ Create company policy/system and SOP (related to clinical development) to meet the regulatory requirements such as GCP

Educational Training work
・ Operate and monitor training of regulatory requirements such as GCP
・ Operate and monitor medical and professional trainings

CRO management work
・ Select a trustee of development work (CRO) and conduct contractual transactions communicating with HW regarding clinical studies related work
・ Monitor the selected CRO and train appropriately when necessary
・ Clinical trials management work
・ Monitor and maintain the storage of the clinical trials have the clinical trials which meet the storage requirements
・ Insure all the clinical trials meet storage requirements

The successful candidate will have solid experience within clinical development especially with quality control and a scientific educational background would be preferred. Native Japanese and intermediate English is also required for this role.

Way Simmons Partnership has offices in Tokyo, Hong Kong and Singapore and provides contingency, advertised and search solutions across the commerce and industry sector. Our recruitment business is categorised as specialist/professional. With many years of experience in search and selection our team of expert recruitment consultants has experience in the following areas:

Executive & Management
Accounting & Finance
Human Resources
Marketing & Sales
Executive Support

We act for Multinational Companies (MNCs), Small to Medium Enterprises (SMEs) and locally grown diversified businesses and employers of choice who understand the value of working in partnership with a totally focused approach to human resource solutions.

All our consultants are able to rapidly understand their clients’ hiring requirements whilst developing a strong relationship of trust with their candidates. Our team prides itself on carrying out their work with the utmost confidentially and integrity and for candidates, there is no charge for the services that we provide.

Way Simmons Partnership is a division of Legal Futures Japan K.K.

Our recruitment business is categorized as specialist/professional and our placements are limited to Japan only. Our service is free of charge. We will apply and follow the laws and principles of all relevant legislation and maintain data privacy at all times. Please refer to www.legalfutures.com to view our Privacy Policy. The person handling personal information is our license holder Matt Anderson who will also handle any complaints.