The role focuses on ensuring participant safety, data integrity, and regulatory compliance across clinical trials in the APAC region including Japan
Job Summary
The role focuses on ensuring participant safety, data integrity, and regulatory compliance across clinical trials in the APAC region including Japan.
Candidates will lead GCP audits of medical institutions, prepare reports, and collaborate with cross-functional teams to resolve quality observations.
The position requires strong bilingual communication skills in both Japanese and English to interact with external stakeholders and internal global teams.
Matching Summary
The role focuses on ensuring participant safety, data integrity, and regulatory compliance across clinical trials in the APAC region including Japan.
Skills & Requirements
Must-have
5+ years GCP auditing experience
Fluent Japanese communication skills
ICH-GCP and PMDA regulation knowledge
On-site and remote audit execution
CAPA proposal and follow-up expertise
Nice-to-have
Veeva Vault QMS system proficiency
Risk-based audit planning capability
Global team collaboration experience
Data analysis and trend identification
Process improvement initiative leadership
Key Requirements
Bachelor's degree or equivalent experience
Minimum 5 years practical GCP auditing experience
Knowledge of ICH-GCP, PMD Law, FDA, and EMA regulations
Experience with clinical trial processes from protocol to reporting