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.

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[Position] Senior Clinical Trial Manager
[Location] 東京都
[Salary] 6.9〜8.6 million JPY ※Experiences and skills will be considered
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[Company Description]
外資系バイオ製薬会社

  • 感染症治療の製品を中心に事業を展開する世界的企業

[Responsibilities]
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.

[Requirements]

  • 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


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Reference: JO-2111-465713
Seniority Level: Mid-Senior level
Job Function: Health Care Provider