Job Detail

Company Description

This position will be offered in the context of a collaboration between University of Bern and Intento SA (www.Intento.ch). Intento is an EPFL spin-off developing a solution for the rehabilitation of paralyzed stroke patients based on functional electrical stimulation. Since 2018, Intento SA is part of the Mindmaze family, the world’s leading Neurotechnology company built on more than a decade of pioneering research at the intersection of virtual reality and neuroscience.

Job Description

We are looking for a Clinical Research Associate to support the execution of a multicentre clinical trial, specifically in the following clinical sites: Lausanne University Hospital (CHUV) and Geneva University Hospital (HUG).

You will:

• Supervise the daily activities at clinical trial sites (in Geneva and Lausanne) including logistics (e.g. patients’ transportation), interventions, reporting activities


• Review data to ensure clinical accuracy and proactively identify trends that may adversely impact data quality


• Provide training to rehabilitation professionals when required


• Be responsible for writing and managing documents for regulatory submissions or for Innosuisse project, in partnership with the project team


• Develop and maintain collaborative relationships with clinical trial sites and Intento personnel


• Provide feedback on the device to the Intento’s development team


• Contribute to the tracking and management of assigned budget


• Report to Intento manager

Qualifications

Skills that we look out for are among

• Education: MS degree in a scientific discipline, preferably in Life Sciences or Biomedical engineering


• Proven experience of clinical project execution and data management, preferably in rehabilitation and in the pharmaceutical/medical device industry


• In depth knowledge of ICH-GCP, the Medical Device Directive ISO 14155; understanding of US and European medical device clinical trial approval procedures (e.g. CE mark, 510K)


• Ease with technology like Microsoft Office, electronic data capture systems etc.


• Good activity planning and priority setting


• Autonomous, motivated and able to learn fast


• Effective communication skills both verbal and written


• Fluent in French (min B2 level) and English (min C2 level), German is a plus

Icing on the cake

• Experience with clinical trials on medical devices


• Experience with technology for neuro-rehabilitation

Additional Information

To be successful, you can illustrate the fact that you have the following abilities:

• Working autonomously: setting tasks and direction under limited supervision


• Oral and written communication: ability to write clearly and succinctly in a variety of communication settings and styles; ability to get messages across that have the desired effect


• Planning accurately: setting objectives and goals; breaking down work into the process steps; developing schedules and task/people assignments; anticipating and adjusting to problems and roadblocks