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Updated 2024-03-22
Activated 2024-03-22

Clinical Trial Manager, APAC

  • Recruiter
  • Manager Level
This posting is managed by: Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
Company Name Company is not publicly visible
Job Type
Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
Medical/Pharmaceutical/Bio/Fabric/Food - Clinical R & D
Industry Pharmaceuticals
Location Asia Japan Tokyo

Job Description Leading the local trial team to deliver results compliant with assigned protocols, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements.

Actively contributing to process improvement and site management, you will train and mentor Site Managers (SMs) and other Local Trial Managers (LTMs).


Description

- You will undertake assessments (country do-ability, and site feasibility) to select suitable trial sites and assign SMs
- Development of the SOP document
- Leading and coordinating local trial and project planning activities including development of local trial specific procedures and tools, recruitment planning, contingency, risk management and budget forecasting
- Management of the local trial budget to ensure accurate financial reporting and trial delivery
- Identification of issues and trends across trial projects
- Acts as the local expert on assigned protocols, developing a strong therapeutic knowledge to support other roles and responsibilities
- You will establish and maintain relationships with external stakeholders such as investigators, study trial coordinators, other site staff, and internal stakeholders.
- Acts as the local expert on regulatory affairs to ensure that the trial is in compliance with local regulatory requirements.


Profile

- BA/BS degree required, preferably in a health or science-related field
- Solid understanding of the drug development process
- Proficiency in both Japanese and English


Job Offer

Involvement in cutting-edge drug development for the global market.




Page Group Japan is acting as an Employment Agency in relation to this vacancy.
Company Info One of the leading pharmaceutical companies globally recognised especially in the field of rare disease.
English Level Business Conversation Level (TOEIC 735-860)
Japanese Level Fluent(JLPT Level 1 or N1)
Salary JPY - Japanese Yen JPY 10000K - JPY 15000K   
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Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社

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