Clinical Study Manager

About the Company

Artidis® AG is a pioneering clinical stage health technology company that aims to set the gold standard in tissue analysis and therapy optimization. By combining its nanotechnology platform for rapid tissue analysis with a holistic data solution, Artidis® accelerates drug discovery, tissue engineering, and personalized treatment.

Responsibilities

• Design, planning, implementation, and management of clinical studies for medical devices
• Manage all aspects of clinical studies including planning, execution, and close-out
• Ensure study conduct complies with approved protocols and Good Clinical Practices (ISO 14155, ISO 20916, or ICH-GCP E6)
• Develop study protocols and operational documents according to regulatory requirements
• Manage resources, timelines, and study-specific training for staff and external partners
• Oversee subject enrollment, clinical monitoring, and site audits
• Track key study activities, metrics, and site/vendor payments
• Conduct remote data monitoring and on-site visits (site initiation, monitoring, and close-out)
• Manage safety documentation and reporting in accordance with QMS and regulatory requirements

Requirements

• Degree in a scientific discipline or related field
• Minimum 5 years of medical device clinical study management experience in a leading position
• Full lifecycle experience in medical device clinical studies (proposal to close-out)
• Advanced hands-on experience with GCP and medical device regulatory guidelines
• Excellent oral and written communication skills in English
• Ability to thrive in a dynamic start-up environment with a hands-on mentality
• Willingness to travel approximately 20%

Preferred Qualifications

• Experience with regulatory submissions to ethic committees and institutional review boards
• Proficiency in managing sponsor and site files within a QMS framework