[innovative Medicine] R&d Gco Japan オンコロジークリニカルオペレーション部 サイトマネージャー（cra）

Johnson & Johnson Innovative Medicine

Chiyoda, Tokyo, Japan
Not specified
3+ years clinical trial monitoring experience
Phase 2 or phase 3 oncology development experience
Global process and ich gcp compliance knowledge
Johnson & Johnson Innovative Medicine is seeking a Site Manager for their Oncology Clinical Operations department in Japan. The role involves overseeing clinical trial processes, including site selection, monitoring, and managing trial-related activities, requiring a strong background in clinical operations

Job Summary

  • The role involves managing clinical trial operations from site selection through database lock, ensuring quality control and regulatory compliance.
  • Candidates must have specific experience in oncology therapeutic areas and handling global studies adhering to FDA, EMA, and ICH GCP standards.
  • The position requires strong communication skills to build relationships with medical institutions and manage complex issues independently.

Matching Summary

Match Score: 85

Johnson & Johnson Innovative Medicine is seeking a Site Manager for their Oncology Clinical Operations department in Japan. The role involves overseeing clinical trial processes, including site selection, monitoring, and managing trial-related activities, requiring a strong background in clinical operations.

Skills & Requirements

Must-have

  • 3+ years clinical trial monitoring experience
  • Phase 2 or Phase 3 oncology development experience
  • Global process and ICH GCP compliance knowledge
  • Site initiation phase management for multiple sites
  • English proficiency (TOEIC 650+)
  • Experience with university or national hospitals

Nice-to-have

  • Leadership in improvement activities
  • Resilience in high-stress environments
  • Constructive dialogue and feedback absorption
  • Experience with foreign pharmaceutical companies
  • Active contribution to project teams

Key Requirements

  • Bachelor's degree in Medicine, Pharmacy, or Biology
  • Minimum 3 years of CRA or clinical trial experience
  • Fluency in English reading and writing
  • Proficiency with EDC and CTMS systems
  • Willingness to travel domestically including air travel

Work Rights

Not specified

Tailored Resume

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