Junior Clinical Project Manager - Medical device - Mont-St-Guibert

Our client is a medical device company, focused on developing and commercializing a disruptive neurostimulation based therapy for the treatment of Obstructive Sleep Apnea (OSA). Headquartered in Mont-Saint-Guibert (Belgium), the Company was co-founded in 2009 by Robert Taub. The company has developed the first and only lead-free neurostimulator, capable of delivering bilateral hypoglossal nerve stimulation for moderate to severe OSA patients, who have failed conventional CPAP therapy.

Your mission

This position is responsible for identifying and developing clinical research protocols including but not limited to small-scale feasibility studies, reimbursement, and new indication clinical assessments. The position works cross-functionally to implement the defined plans using internal and external resources.

Your responsibilities and project duties

  • Work on all aspects of pre- and post-market clinical studies including development of protocols, CRFs, IB, and ICF
  • Collaborate with relevant staff including regulatory affairs, marketing, research & development, reimbursement and outcomes planning
  • Prepares clinical reports for regulatory and medical purposes
  • Participates in the dissemination of clinical information to the clinical team members and extended core team members, as appropriate
  • Collaborate with clinical project/program managers and clinical operations staff with execution of the study protocol

Your profile

Technical skills required

  • PhD or Master in Medical device Engineering, Biotechnology or Pharmaceutical sciences or related
  • Or Bachelor’s degree + additional experience
  • 3 to 7 years’ experience in clinical/scientific research, medical devices/pharmaceutical clinical trials, including minimum 2 years’ experience working with clinical professionals within a team, as well as working in a cross-functional product development setting
  • Fluency in English. Any other language is an asset
  • Good knowledge of GCP/GLP
  • Proficiency in MS Word, Excel and PowerPoint
  • CE mark and FDA submission experience a plus
  • Experience with Active Implantable Medical Devices and supporting clinical studies is an asset

The ideal candidate

  • Good communication, prioritization, organizational and time management skills
  • Team player with positive constructive attitude to solve problems
  • Eager to learn, stress resistant, Strong self-development abilities and able to work independently
  • Willingness to manage project independently

Job info and details

  • Permanent contract 
  • Full time job on site 
  • Location : Mont-Saint-Guibert (Belgium)

 

image

Nos offres dans le même secteur

Our client is an international start-up company, a pioneer in the medical devices sector. They work with cutting-edge hardware & software in the sector and their teams are composed of experts in their field. To reinforce their team in the Louvain-la-Neuve area, they are looking for an experienced Mobile App Test Engineer.

lire plus  Postuler


Our client is an international start-up company, a pioneer in the medical devices sector. They work with cutting-edge hardware & software in the sector and their teams are composed of experts in their field. To reinforce their team in the Louvain-la-Neuve area, they are looking for an experienced BLE Embedded Software Engineer (Freelance or Permanent).

lire plus  Postuler


Digital Orthopaedics is a digital Health company providing worldwide access to a comprehensive Clinical Decision Support System (CDSS) for musculoskeletal pathologies. Our ambition is to improve patient treatment by providing caregivers, surgeons patients and medical devices companies with a state of the art CDSS. Our mission is to identify the optimum treatment and surgical therapeutic plan for each patient and assist medical devices companies to conduct virtual clinical studies for the testing of implants and prosthetic ankles. If you are sharing our vision of developing life-improving services and if you are looking for digital health development challenges amongst a dynamic and innovative team, consider collaboration with our fast-growing company. (http://www.digital-orthopaedics.com/)

lire plus  Postuler


Our Client is medical device company, focused on developing and commercializing a disruptive neurostimulation based therapy for the treatment of Obstructive Sleep Apnea (OSA). Headquartered in Mont-Saint-Guibert (Belgium), the Company was co-founded in 2009. The company has developed the first and only lead-free neurostimulator, capable of delivering bilateral hypoglossal nerve stimulation for moderate to severe OSA patients, who have failed conventional CPAP therapy.

lire plus  Postuler