AD/Director, Clinical Monitoring

Tokyo, Tokyo N/a

Posted: 02/01/2026 Employment Type: Direct Hire/Perm Job Category: Clinical Development and Operations Job Number: 625259 Is job remote?: No Country: Japan

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%
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