Senior Clinical Trial Manager - バイオ製薬会社

勤務地 東京都
雇用形態 正社員
給与 ¥6900000.00 - ¥8600000.00 (年収)
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
職種 臨床試験 / CRA / CRC,
お問合せ Hidetoshi Sato
JOB ID JO-2111-465713

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[Position] Senior Clinical Trial Manager
[Location] 東京都
[Salary] 6.9〜8.6 million JPY ※Experiences and skills will be considered

[Company Description]

  • 感染症治療の製品を中心に事業を展開する世界的企業

The position is responsible for managing Japan portion of all phase 1-4 clinical trials for various therapeutic areas in partnership with global/regional clinical operations team and other functions to accomplish study objectives under supervision of the CTM/SCTM and/or CPM/AD of Japan Clinical Operations.


  • Provide a local expertise for development of Japan specific study timeline and managing clinical trial to accomplish study objectives with meet timelines and regulatory requirements
  • Support CTM/SCTM to develop RFPs, select CROs/vendors for Japan portion
  • In partnership with Global Clinical Operations, oversee CRO for ensuring study quality by confirming update from CRO, conducting co-monitoring visits, TMF and assisting with the resolution of specific operational issues under supervision by CTM/SCTM and/or CPM/AD Japan Clinical Operations
  • Under supervision, prepare and/or review the relevant parts of any regulatory documents including translated ones for clinical trial and archive documents appropriately
  • Establish good relationship with investigators and manage them to accelerate the development
  • Oversee study sites/investigators and CRO, by review of source data and regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, Monitoring Plan and TMF plan as required under supervision by CTM/SCTM and/or CPM/AD Japan Clinical Operations
  • Prepare and maintain Post Marketing Clinical Trial (PMCT) and may support the Post Marketing Surveillance (PMS) by collaborating with Late Phase team, if needed under supervision by CTM/SCTM and/or CPM/AD Japan Clinical Operations
  • Participates in local, departmental, interdepartmental or strategic initiatives under general supervision
  • Work experiences in clinical operation for 5-7 years (member of the study team or supporting to lead clinical trials, if any)
  • Experiences in oversight of CROs and vendors are preferred
  • Experiences in source data verification (also PMDA inspection of clinical trial, if any)
  • Through knowledge and understanding of Japanese Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials are required
  • Experiences in managing KOLs, if any
  • Must have demonstrated capability to manage multiple tasks simultaneously, plan proactively and accomplish goals using well-defined instructions and procedures
  • Good skills of communication, reading and writing in English and translation into Japanese (>700 TOEIC)
  • Hands-on involvement is a must (effective use of external resources)
  • Strong communication and influence skills and ability to create a clear sense of direction is necessary
  • International and domestic Travel is required

Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Reference: JO-2111-465713
Seniority Level: Mid-Senior level
Job Function: Health Care Provider