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AD/Director, Clinical Monitoring
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
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Provide direct line management and leadership to Clinical Monitoring management teams, ensuring effective performance, engagement, and development
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Oversee CRA resourcing and allocation across studies and sites to ensure optimal coverage and delivery
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Contribute to workforce planning, recruitment, and retention strategies for the Clinical Monitoring function in Japan
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Ensure robust training, onboarding, and ongoing oversight of CRA Managers and monitoring teams
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Support local and global leadership in achieving Clinical Monitoring operational metrics, KPIs, and quality objectives
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Act as a senior operational leader within Japan, partnering cross-functionally to support study delivery and compliance
Candidate Profile
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Bachelor’s degree with extensive experience in Clinical Monitoring within a CRO or pharmaceutical environment
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10+ years of industry experience, including:
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4+ years’ hands-on experience as a CRA
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6+ years’ experience in CRA management or equivalent leadership roles
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Advanced knowledge of ICH-GCP and J-GCP requirements
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Strong people leadership skills, with a proven ability to mentor, motivate, and develop high-performing teams
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Excellent English communication skills (written and verbal); Japanese language skills advantageous depending on background
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Proficient in Microsoft Office and clinical operations systems
Travel
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Up to approximately 10%
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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