About the company:
Nyxoah is an innovative medical device company based in Belgium that is currently developing a novel neurostimulation technology to treat Obstructive Sleep Apnea (OSA) for patients that have failed or refused continuous positive airway pressure (CPAP) therapy. The mission of Nyxoah is to provide our users with the freedom to enjoy life to its fullest by delivering reliable, durable and harmonious solutions to treat OSA.
Nyxoah is recruiting a junior Clinical Project Manager to join our clinical research team based in Belgium.
• Prepare and/or review study documents including protocols, CRFs, IB, and ICF
• Participate to the regulatory files preparation, when applicable
• Maintain and check TMF on a regular basis
• Collaborate with site personnel, IRBs/ECs, Competent Authorities, contractors/vendors, and internal departments (QA, R&D, Manufacturing)
• Ensure successful and high quality delivery of the study in accordance with ICH/GCP and other regulatory requirements
• Develop study contracts and budgets
• Assist in preparing reports and articles if needed
• May support clinical trial design and strategy
• Organize internal team meetings
• Identify resource requirements, prepare study management and monitoring plan
• Perform other related duties and tasks, as required
• At least 2 years of experience in similar position
• 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
• Demonstrated computer skills preferably spreadsheets, word processing, database, and other applicable software programs
• Good level of English
• Extensive knowledge of ICH/GCP regulations and guidelines
• CE mark and FDA submission experience is a plus
Are you interested in working with Nyxoah? Don’t hesitate and apply as soon as you can! Please forward your resume and a cover letter addressing the above selection criteria to [email protected]
Should you have any additional questions, do not hesitate and contact us immediately.