CDI - Clinical study manager - F/H

***** basé à Vernon 27200 *****

Our Mission

At SYSNAV Healthcare, we are striving to provide more accurate & faster evidence of therapeutic efficacy on patient mobility. Our purpose is to unlock the potential of real-world data in the medical field by adapting extremely precise motion-capture solutions based on magneto-inertial technology to the needs of healthcare professionals and patients.

More specifically, we have developed, approved & manufactures two CE medical devices: ActiMyo and Syde that are deployed in clinical trials. They are composed of wrist-strapped or ankle-strapped magneto-inertial sensors, and a station for data & battery management. Those two devices are the only wearables which can compute the SV95C (Stride Velocity 95th centile) the first Digital Clinical Outcome Assessment approved by the EMA in Duchenne Muscular Dystrophy.

We are the first global player to ever qualify a digital endpoint to the European Medicines Agency (EMA) as representative of neuromuscular patients’ motor functions and suitable for use in clinical studies. We now look to become the standard solution for motor function assessment based on real-world evidence.

SYSNAV, our mission is to help bring new digital endpoints to light. Working at SYSNAV means applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in pharmaceutical and biotech companies.

These customers have new therapeutic ideas and need a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. Ultimately, you’ll help make a positive difference in patients’ lives.

The role & responsibilities

Operations and supervision of worldwide multi-center trials

• Provide functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution of our medical devices and filing study documentation.
• Track and supervise collection of ongoing study data for our data analyses and for regular project status reporting.
• Assist the Project Team with the day-to-day management of clinical studies as required.
• Ensure adherence to GCP, ICH, SOPs, and study protocols.

Preparation, coordination, and management

• Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members.
• Presenting at investigator meetings
• Developing project specific clinical staff training.
• Train, mentor and/or supervise junior staff.

Who we are looking for

• Master’s degree in life sciences or clinical research related field.
• Experience/internships dealing with global multi-center clinical trials on phase 2/3 clinical trials
• An interest in neuromuscular and rare diseases
• A strong interest for digital transformation of the pharma industry and clinical trials
• Exceptional skills around self-organization and as you will be responsible for multiple projects
• Client satisfaction oriented, ensuring operational excellence
• Full fluency in written as well as spoken English & French