Clinical Affairs Specialist

Abbott

Tokyo, Japan
Clinical trial management system (ctms)
Study documentation management
Gcp compliance
Manage study documentation and operational progress using CTMS while maintaining the highest quality standards in clinical study execution

Job Summary

  • Manage study documentation and operational progress using CTMS while maintaining the highest quality standards in clinical study execution.
  • Oversee documentation and study management support across clinical studies, ensuring compliance with regulations and SOPs.
  • Collaborate with APAC and global partners to drive continuous process improvements and contribute to innovation.

Matching Summary

Manage study documentation and operational progress using CTMS while maintaining the highest quality standards in clinical study execution.

Skills & Requirements

Must-have

  • Clinical Trial Management System (CTMS)
  • Study documentation management
  • GCP compliance
  • ISO14155 compliance
  • Fluent in English and Japanese

Nice-to-have

  • Proactive problem-solving
  • Continuous process improvement
  • Team collaboration
  • Mentoring junior staff

Key Requirements

  • Bachelor’s degree or equivalent
  • >2 Years of Field CRA experience
  • Experience with J-GCP, Ethical Guidelines, Clinical Trial Act
  • Full knowledge of GCP

Work Rights

Not specified

Tailored Resume

Cover Letter