Job Description
Job Title:
Associate Director / Director, Clinical Monitoring
Location:
Tokyo, Japan
Overview
A global clinical research organisation is seeking an experienced Associate Director / Director of Clinical Monitoring to lead and scale its Clinical Monitoring function in Japan. This role plays a critical leadership position within the local Clinical Operations organisation, with responsibility for people leadership, resource planning, and delivery of high-quality monitoring across a broad clinical portfolio.
The organisation supports Phase I–IV clinical development programs across multiple therapeutic areas, leveraging strong scientific, regulatory, and operational expertise to deliver studies efficiently and compliantly.
Key Responsibilities
- Provide direct line management and leadership to Clinical Monitoring management teams, ensuring effective performance, engagement, and development
- Oversee CRA resourcing and allocation across studies and sites to ensure optimal coverage and delivery
- Contribute to workforce planning, recruitment, and retention strategies for the Clinical Monitoring function in Japan
- Ensure robust training, onboarding, and ongoing oversight of CRA Managers and monitoring teams
- Support local and global leadership in achieving Clinical Monitoring operational metrics, KPIs, and quality objectives
- Act as a senior operational leader within Japan, partnering cross-functionally to support study delivery and compliance
Candidate Profile
- Bachelor's degree with extensive experience in Clinical Monitoring within a CRO or pharmaceutical environment
10+ years of industry experience, including:
4+ years' hands-on experience as a CRA
6+ years' experience in CRA management or equivalent leadership roles
Advanced knowledge of ICH-GCP and J-GCP requirements
- Strong people leadership skills, with a proven ability to mentor, motivate, and develop high-performing teams
- Excellent English communication skills (written and verbal); Japanese language skills advantageous depending on background
- Proficient in Microsoft Office and clinical operations systems
Travel
- Up to approximately 10%
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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