Clinical Affairs Senior Manager (IGTD)
Your role:
Exciting opportunity to lead the team working on Cardiac and Endovascular registration projects for Philips Image-guided Therapy, which includes novel technologies integrated by therapeutic devices and visualization systems.
- Lead the Japan IGTD CA Team 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 Philips’ 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 RA/CA as a solid line and the head of IGTD CA/MA as a dotted line.
You're the right fit if:
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.
- + 3 years' experience in people management.
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
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