Clinical Program Manager

What you'll do

Your role

• Clinical Trial Pipeline: Oversee the development of our clinical trial pipeline and related communication with the scientific advisory board.
• Clinical Trial Management: Lead end-to-end Clinical Trial Management, including planning, execution, CRO communication, quality assurance, budget and timeline adherence, site selection and management, data monitoring, source data verification, and submissions and communications with Ethics Committees and Competent Authorities.
• Regulatory Compliance: Ensure clinical trials follow US and EU regulations (FDA, EMA) and maintain up-to-date knowledge of regulatory requirements, and oversee all clinical investigation-related standard operating procedures.
• Data Management and Reporting: Oversee clinical data management, including collection, analysis, and reporting, provide recommendations based on trial results, and lead CRF development, database development (e.g., Castor), and the development of tools for study metrics management.
• Post-Market Clinical Follow-Up: Implement strategies to monitor product safety and performance post-market, ensuring compliance with EU MDR.
• Cross-functional Collaboration: Work with various departments (R&D, regulatory, medical) to integrate clinical research into product development.

What you need

Your profile

• MD, MSc, PhD, or equivalent in a relevant scientific or medical field
• 5+ years of experience in clinical research within the medical device industry, ideally Software as Medical Device (SaMD) and artificial intelligence
• Proven track record of successfully managing all phases of clinical trials, from early-stage to post-marketing studies
• Extensive knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH-GCP)
• You have a commercial focus in the application of regulatory requirements
• Excellent project management and communication skills to coordinate regulatory agencies and consultants
• Display, encourage, and inspire a culture of excellence across our entire organization
• Experience with AI/ML-based medical devices and cardiology medical devices is preferable