At Powerful Medical, we are building a global life-saving technology. Our certified product diagnoses cardiovascular diseases (#1 cause of death globally) by scanning ECGs using AI and machine learning. We’re currently cooperating with several leading healthcare providers within the US and the EU and are backed by US, European, and Israeli VCs.

As a Clinical Program Manager at Powerful Medical, you will play a key role in driving our innovative medical technologies forward. In this position, you will be a crucial part of all clinical research activities, from design and planning to execution and management of clinical studies. You’ll ensure our investigations run smoothly and on time and meet top regulatory standards in both the US and Europe while exploring new approaches that enhance research quality. Working closely with cross-functional teams, you’ll help bring breakthrough medical solutions to market, ensuring that clinical investigations are conducted efficiently, ethically, and in alignment with the company’s strategic goals. This is an opportunity to lead, innovate, and make a significant impact in healthcare.

Your role

• Clinical Investigation Pipeline: Oversee the development and monitoring of our clinical investigation pipeline and communication of progress with the scientific advisory board.
• Clinical Investigation Management: Lead end-to-end Clinical Investigation 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 investigations 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 investigation 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.

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 medical device clinical investigations, 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