A global medical technology leader is hiring a Clinical Research Manager to lead a team of monitors across multiple clinical trials in Japan. In this high-impact role, you will oversee monitoring operations, ensure protocol and regulatory compliance, mentor staff, and drive consistent trial execution. This role works closely with cross-functional teams and international stakeholders, making it ideal for professionals with a strong clinical operations background in regulated environments.
Key Responsibilities
- Lead monitoring strategy and operational planning aligned with study designs
- Oversee monitor assignment, workload management, coaching, and performance reviews
- Review monitoring documentation regularly and conduct targeted training sessions
- Supervise monitoring staff in activities such as site initiation, ethics coordination, documentation, and site contract processes
- Foster collaborative relationships with study sites, investigators, and CRO partners
- Ensure adherence to protocols, monitoring plans, and regulations; address deviations with CAPA
- Manage data entry tracking, safety reporting, issue resolution, and inspection readiness
Required Skills and Qualifications
Experience:
- 10+ years of clinical monitoring experience in regulated clinical studies
- 5+ years of leadership experience managing monitors or overseeing site-level operations
- Experience in either pre-market or post-market clinical trials accepted
Soft Skills:
- Proven team leadership and mentoring capability
- Strong understanding of GCP, clinical study operations, and documentation standards
- Excellent organizational and communication skills across internal and external stakeholders
Language Requirements:
- Japanese: Native level
- English: Conversational to Business level
Preferred Skills & Qualifications
- Experience in device or pharmaceutical trials with PMDA involvement
- Background working with global teams or CRO/vendor management
- Familiarity with audit preparation and submission documentation
About the Company
This organization is a globally recognized medical device company, delivering innovative solutions across cardiovascular, surgical, neurological, and diabetes care. Operating in over 150 countries, they partner with healthcare providers to improve patient outcomes through clinical innovation and operational efficiency. Their collaborative culture emphasizes impact, continuous learning, and global teamwork.
Why You'll Love Working Here
- Be part of a market-leading clinical research team
- Gain visibility with regional and global leadership
- Work with international teams across therapeutic areas and functions
- Join a respected medical community that values your expertise
- Enjoy a flexible work environment with remote options and strong benefits
Don't Miss Out - Apply Now!
