人材紹介マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K.
メディカル/医薬/バイオ/素材/食品 - 臨床開発系
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).
- 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.
- 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
Involvement in cutting-edge drug development for the global market.
To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Dr. Philipp Berndt on +813 6832 8945.
|One of the leading pharmaceutical companies globally recognised especially in the field of oncology.|
|英語能力||ビジネス会話 (TOEIC 735-860)|
|年収||日本・円 1000万円 〜 1200万円|