🔎 Clinical Performance Studies Expert

We are seeking a dynamic and experienced Expert in Clinical Performance Studies to join our team, specializing in In Vitro Diagnostics (IVD). In this role, you will be designing, executing, and overseeing clinical performance studies for in vitro diagnostic (IVD) products.

Requirements

• Organize and execute assigned Clinical Performance Studies, including protocol development, monitoring activities and reporting.
• Protocol Development: Develop study protocols and project plans while ensuring alignment with project objectives, budget and regulatory requirements.
• Data Analysis & Reporting: Analyze complex clinical performance data, interpret results and draft high quality clinical performance study documentation.
• Regulatory Compliance: Ensure all studies are conducted in compliance with international regulations, including IVDR, ISO 20916, and other relevant guidelines.
• Collaboration & Communication: Work closely with internal teams, customers, and clinical sites to ensure successful study execution and data integrity.
• Training and monitoring: Provide training to study sites and conduct monitoring activities

Benefits

• Attractive and competitive salary package
• Job security
• Continuous journey of learning and development
• Global success story
• Award-winning company