Clinical Project Coordinator

About the Wyss Center for Bio and Neuroengineering, Geneva, Switzerland
The Wyss Center is an independent, non-profit, research organization that innovates and accelerates technologies and therapies to transform the lives of people with neurological and mental health disorders. The Center pursues transformational technologies in artificial intelligence, bio- and neuroengineering to restore essential neural functions and deliver precision therapeutics for people with debilitating neurological and mental health disorders.
Based at Campus Biotech in Geneva, Switzerland, the Wyss Center partners with faculty, clinicians and industry, in Switzerland and internationally, to drive innovation and maximize clinical impact. The Wyss Center was established by a generous donation from the Swiss entrepreneur and philanthropist Hansjörg Wyss in 2014. Additional resources from funding agencies and other sources help the Wyss Center accelerate its mission.

About the Position
The Clinical Project Coordinator will play an integral role at the Wyss Center, working both independently and collaboratively to coordinate the Center's clinical activities and activities related to the upcoming precision neuromodulation center. This center is a human-centered initiative born from a partnership between the Wyss Center (and its affiliated start-ups), the Hospital of Geneva (HUG) and the State of Geneva, aimed at providing patients access to cutting-edge technologies.
The ideal candidate is an experienced clinical coordinator with a proven track record in managing clinical studies, collaborating with clinicians, regulatory authorities and ethics committees throughout the development, submission and conduct of clinical studies. The ideal candidate has experience or a strong interest in neuroscience.
Core competencies include an in-depth understanding of clinical research processes, regulatory knowledge, as well as project management and communication capabilities.
They will report directly to the Wyss Center’s Regulatory and Clinical Manager.

Key responsibilities
In their position, the Clinical Project Coordinator will:
Coordinate and implement clinical studies for new and existing technologies, including evaluating, preparing, submitting and running studies in which the Wyss Center is involved.
Determine the clinical strategy in coordination with the clinical partners, product managers, and the clinical and regulatory affairs manager.
Manage interactions with relevant National Competent Authorities and, where applicable, ethics committees regarding clinical study submissions.
Facilitate collaboration between clinicians, research groups and start-ups.
Ensure clinical affairs processes align with Wyss Center’s Quality Management System.
Proactively address compliance issues to uphold regulatory standards.
Help establish 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 experience in clinical affairs within the medical device industry (PhD is an asset).
Strong knowledge of EU and Swiss medical device regulations, including the MDR (EU) 2017/745.
Experience or knowledge with clinical investigations for medical devices, including 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, with excellent verbal and written communication skills and organizational skills.
Knowledge of neurology devices and the relevant market is a plus.
Fast learner, enthusiastic, ability to mentor peers.
High sense of responsibility couples with a good team spirit.
Fluent in English; proficiency in French is a plus.