Senior Manager of Clinical Project Manager, Class 3/4

Publication date 2025/08/27

Work Location , Expected Annual Income :

Tokyo,12.0M ～ 16.0M

About the Company :

Global European Medical Equipment Manufacturer

Responsibilities :

Your role:
Exciting opportunity to lead the team working on Cardiac and Endovascular registration projects for Image-guided Therapy, which includes novel technologies integrated by therapeutic devices and visualization systems.

- Lead the Japan Senior Manager and all clinical studies and evidence development projects that the team is responsible for to proceed with the plan.
- Lead developing local clinical evidence development strategy and strategic discussion with the local RA team and other related stakeholders, including - - - - Business Unit, R&D, and Market Access & Reimbursement to accelerate projects and fast serve patients.
- Proactively identify risks within clinical evaluation strategies, plans, products and propose alternate approaches.
- Provide interpretation of local regulations to BU partners and ensure necessary requirements are fully deployed.
- Stay informed of new regulations and technologies relevant to endovascular therapeutics.
- Plan and execute clinical evidence development, GCP compliance review of foreign operated clinical trials, and PMS study as a condition of approval according to the regulations and aligned with local business needs.
- Manage interactions with MHLW/PMDA/KTLs and maintain a productive working relationship.
- Manage CRO services to ensure meeting with business needs and operational policies.
- Review and approve clinical documentation according to the GCP/GPSP requirements.
- Oversee clinical administration activities.
- Report to the Head of Japan as a solid line

Benefits :

- [Contract period] No set period
- [Trial period] There is a trial period (in principle, 6 months from the date of joining)
- [Job Description] (Immediately after employment) As above (Scope of change) Job duties as determined by the company
- [Workplace] Tokyo, Japan
- [Working hours] 9:00-17:30　Break time: In principle, 12:00-13:00?
- [Work style] Hybrid (3 days a week in the office, up to 2 days a week remote work possible)??????????????
- [Holidays] Every Saturday (regular holiday), Sunday (statutory holiday), national holidays, New Year's holidays (December 29th - January 4th)
- [Vacation]　Up to 20 days of paid vacation in the first year (20 days from the 2nd to 5th years / 25 days from the 6th year onwards), Care Leave (10 days per year), Sick Leave (up to 30 days per year), etc.
- [Salary] Basic salary: Annual salary of 10 to 14 million yen, depending on experience
- [Bonus] Incentive 20%

[Allowances] Commuting allowance provided
[Insurance] Social insurance (Employee's pension insurance, health insurance) / Labor insurance (Employment insurance, Workers' accident compensation insurance)
- [Retirement benefits system] Two types of retirement benefits: lump-sum retirement benefit and defined contribution pension plan
- [Training system] Various online training programs and post-employment support training available
- [Internal recruitment system available] We have an internal recruitment system in place to promote career changes within the company.

Required Experience / Abilities / Skills :

1. Experience.
- +10 years’ experience in clinical operation including medical device.
- Experience in the Study Manager role in medical device clinical studies and GCP compliance inspections by PMDA.
- Maintains extensive knowledge of the PMD act, GCP ordinance, GPSP ordinance, ICH guidelines, and ISO13485.
- Experience or working knowledge of EVT or any cardiovascular therapeutic medical devices.

2. Skills.
- Self-motivated and able to prioritize handling multiple tasks/responsibilities.
- Capable of thinking critically, logically, and strategically
- Bachelor of Science Degree (Master preferred)
- Fluent in Japanese and English

Contact Information :

JAC International, Healthcare Team
Dunstan Matthews
Email: d-matthews@jac-international.jp

If you are interested, email us for inquiry!

JOB ID : IJB2009304