Senior CRA

Location Tokyo, Tokyo
Job type Permanent
Salary 7,000,000 - 11,000,000 JPY
Reference 33681

【COMPANY OVERVIEW】

Global Leader in Chronic Diseases

【JOB RESPONSIBILITIES】

You will be in charge of all clinical development work, facility selection, monitoring work, and clinical trial completion. You need to make sure that all clinical trial processes are conducted, recorded and reported in accordance with the SOP-containing runbooks, clinical trial protocol, ICH / J-GCP and other applicable legislation.

  • Investigate hospitals/medical institutions based on the situation of the clinical trial implementation plan

  • Propose agreement with hospitals/medical institutions about the clinical trial implementation plan, including the submission of documents to the clinical trial review committee and preparation of the clinical trial

  • Facility management

  • Introduction of investigational drug and provision of safety information

  • Implementation of Risk based monitoring (RBM) for the purpose of maintaining the quality of clinical trial data

  • Preparation and response to FDA/EMA/PMDA audit inspections

  • Training junior CRAs with the help of the line manager

  • Participate in global tasks in collaboration with HQ staff and regional staff

【WHY YOU SHOULD APPLY】

  • Company offers great global exposure

  • Experts in their main area but pipeline is expanding and getting bigger

  • Work from home options

【REQUIREMENTS】

  • Person who has a series of practical experience in clinical development work

  • Knowledge of GCP, SOP, other related rules and medical / pharmacy

  • Experience at a new drug manufacturer is a plus

【FOR FURTHER INFORMATION】

  • Click apply

OR

  • Contact Pauline:

pauline.mares@cornerstone.jp

050 1742 5298