What you'll do
- Leadership and Strategy: Create and lead the strategy for the clinical research team, align with business objectives, and drive innovation and excellence
- Clinical Trial Management: Lead the planning and execution of clinical trials, ensuring quality, budget, and timeline adherence, and manage site selection
- Regulatory Compliance: Ensure clinical trials follow US and EU regulations (FDA, EMA) and maintain up-to-date knowledge of regulatory requirements
- Data Management and Reporting: Oversee clinical data collection, analysis, and reporting, and provide strategic recommendations based on trial results
- 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
- Team Development: Build and manage a high-performing clinical research team, fostering growth and development
