Clinical Project Coordinator / Clinical Project Coordinatoress

About the Wyss Center for Bio and Neuroengineering, Geneva, Switzerland

The Wyss Center is an independent, non-profit research organization dedicated to innovating and accelerating technologies and therapies that transform the lives of individuals suffering from neurological and mental health disorders. The Center aims to develop transformational technologies in artificial intelligence, bioengineering, and neuroengineering to restore essential neural functions and deliver precision therapeutics for those affected by debilitating conditions.

Located at Campus Biotech in Geneva, Switzerland, the Wyss Center collaborates with faculty, clinicians, and industry partners both locally and internationally to drive innovation and maximize clinical impact. Established in 2014 through a generous donation from Swiss entrepreneur and philanthropist Hansjörg Wyss, the Center continues to benefit from additional resources provided by funding agencies and other sources to accelerate its mission.

About the Position

The Clinical Project Coordinator will play a vital role within the Wyss Center, working independently and collaboratively to oversee the Center's clinical activities, particularly related to the upcoming precision neuromodulation center. This initiative is centered around providing patients access to cutting-edge technologies through a partnership involving the Wyss Center, its affiliated start-ups, the Hospital of Geneva (HUG), and the State of Geneva.

The ideal candidate will be an experienced clinical coordinator with a strong track record in managing clinical studies, collaborating effectively with clinicians, regulatory authorities, and ethics committees throughout the lifecycle of clinical research. The candidate should possess experience or a keen interest in the field of neuroscience. Core competencies include a comprehensive understanding of clinical research processes, regulatory knowledge, project management skills, and effective communication capabilities. This position reports directly to the Wyss Center’s Regulatory and Clinical Manager.

Key Responsibilities

In this role, the Clinical Project Coordinator will:

• Coordinate and implement clinical studies for new and existing technologies, evaluating, preparing, and conducting studies in which the Wyss Center is involved.
• Determine the clinical strategy in coordination with clinical partners, product managers, and the clinical and regulatory affairs manager.
• Manage interactions with relevant National Competent Authorities and, when applicable, ethics committees regarding clinical study submissions.
• Facilitate collaboration among clinicians, research groups, and start-ups.
• Ensure clinical affairs processes are aligned with the Wyss Center’s Quality Management System.
• Proactively address compliance issues to uphold regulatory standards.
• Assist in establishing partnerships with academic institutions and research organizations.
• Provide training and mentorship on clinical affairs topics, including clinical investigations, evaluations, and literature reviews.

Required Competence and Experience

• MSc in Biomedical Engineering or a related Life Science discipline, with 3-5 years of experience in clinical affairs within the medical device industry (PhD is an asset).
• Strong knowledge of EU and Swiss medical device regulations, including MDR (EU) 2017/745.
• Experience or knowledge of clinical investigations for medical devices, covering MEDDEV 2.7/1 rev.4 and EN ISO 14155-2021.
• Proven experience leading clinical evaluation processes for novel technologies.
• Experience interacting with National Competent Authorities (e.g. Swissmedic) and Notified Bodies.
• Strong attention to detail, along with excellent verbal and written communication and organizational skills.
• Knowledge of neurology devices and the relevant market is a plus.
• Fast learner, enthusiastic, and capable of mentoring peers.
• Demonstrates a high sense of responsibility alongside good team spirit.
• Fluent in English; proficiency in French is an asset.

Apply online using the form below. Only applications matching the job profile will be considered.