Clinical Affairs Specialist / Mgr

Tokyo 23 Wards Permanent Foreign Multinational
  • 世界有数の医療機器メーカーで働く
  • 将来的には薬事申請業務もご担当いただくことを想定しております。

About Our Client

  • World leading Medical Device / Health Technology company with a focus on innovation and patient care
  • Global company with a passionate, collaborative and diverse team

Job Description

  • Responsible for team's interface and collaboration with Key Opinion Leaders(KOLs) and management.

  • Lead clinical scientific discussions with PMDA, including proposed clinical investigations.

  • Lead the confirmation for clinical data, study results, and essential documents for the clinical data package, and lead the regulatory inspection by PMDA

  • Develop, revise and maintain study design and outlines, scientific rationale, Protocol Synopsis and full protocol of the local clinical studies/CIS/PMS.

  • Lead to implement study protocol including knowledge transfer to clinical operation team, execution of clinical study oversight of clinical studies/CIS/PMS in Japan, and also to prepare for the following documents as applicable

  • Lead to execute medical monitoring while conducting independent clinical study in Japan (Local study).

  • Lead to develop Clinical Study Report (CSR) of the Local study, relevant parts of Summary of Technical Documents (STED), including discussion on appropriate data interpretation from top line results and tabulations, and key message clarification.

The Successful Applicant

  • CROマネジメントのご経験を有する方

  • 薬学、バイオロジー、エンジニアリング系学部ご出身の方

What's on Offer

  • 将来的には薬事申請業務もご担当いただくことを想定しております。
  • 世界有数の医療機器メーカーで働く。
Ed Marsden
Quote job ref
Phone number
+813 6832 8981

Job summary

What is your area of specialisation?
Healthcare / Pharmaceutical
Tokyo 23 Wards
Job Type
Consultant name
Ed Marsden
Consultant phone
+813 6832 8981
Job Reference
Company Type
Foreign Multinational