Freelance Clinical Research Associate (m/f/d)

EPM Scientific is partnering with a global medical device organisation seeking experienced freelance Clinical Research Associates to support clinical studies across Japan.

Key Requirements:

• Strong background in clinical research within the medical device, biotechnology, or pharmaceutical industry
• Experience supporting and/or monitoring clinical trials from start-up through close-out, including site activation, regulatory submissions, and study maintenance activities
• Knowledge of ICH-GCP, ISO 14155, and applicable local regulatory requirements
• Experience working with clinical sites, Ethics Committees, and study documentation (eTMF, CTMS, regulatory files)
• Strong stakeholder management and communication skills
• Fluent in Japanese and English
• Previous medical device experience is highly preferred

Responsibilities:

• Support site start-up, regulatory submissions, site activation, enrollment, follow-up, and close-out activities
• Ensure study documentation is accurate, complete, and inspection-ready throughout the study lifecycle
• Act as the primary liaison between study teams, sites, and cross-functional stakeholders
• Monitor study progress, identify risks, and support successful trial delivery
• Maintain compliance with ICH-GCP, ISO 14155, SOPs, and local regulations

Contract Details:

• Start Date: ASAP
• Location: Japan (Remote)
• Contract Type: Freelance
• Commitment: 1.0 FTE
• Duration: Initial 12-month contract with strong possibility of extension
• Rate: Competitive hourly rate, dependent on experience

If you're interested, please apply with your CV. If this opportunity isn't suitable for you, feel free to share it with your network.