Sr. Clinical Study Lead

Tokyo Permanent 10,000,000¥ - 12,000,000¥ Foreign Multinational
  • Leading In-Vitro Diagnostics company
  • Key role in the project core team

About Our Client

Leading In-Vitro Diagnostics company. Global presence with 35 subsidiaries in over 25 countries and a distribution partner network in more than 60 countries.

Job Description

- Accountable for the development and execution of all study associated documentation including protocols, investigator brochure, informed consent, contracts, and reports, in compliance with relevant regulations, guidelines and SOPs.

- Accountable for study submission to IRB/IECs and for authoring Competent Authority submissions and may also submit to other Regulatory authorities.

- Accountable for managing and tracking of clinical studies and budget, ensuring study completion in a timely manner within budget, escalating potential issues, setting up internal and external communications for correction, trouble shooting, and prevention planning.

The Successful Applicant

- Bachelor's degree in, life sciences, biomedical or medical related areas

- Minimum 5 years working experience of clinical study within vitro diagnostic devices

company

- Working experience in Clinical Affairs/Operations and experience with diagnostic clinical

studies

What's on Offer

Development of a growing business unit directly under APAC. Career opportunities on a truly global scale.

Contact
Dr. Philipp Berndt
Quote job ref
4179007
Phone number
+813 6832 8945

Job summary

Function
Specialisation
Location
Job Type
Consultant name
Dr. Philipp Berndt
Consultant phone
+813 6832 8945
Job Reference
4179007
Company Type