Clinical trials and medical research on the international market

Our client is a dynamic, ambitious company in the Swiss Midlands. Thanks to its significant innovative strength, it has established itself on international markets with femtosecond laser technology and diagnostic devices for ophthalmology. Its economically sound starting position is making possible further investments in the medium term in favour of new operating techniques in the field of ophthalmology. The Clinical & Medical Affairs department is being expanded. We are looking for an agile, young, dynamic individual – male or female – as a

Clinical Affairs Manager

You will be carefully and thoroughly instructed in your duties by your employer. You will receive insight into our devices and technology and become familiar with the different applications, ophthalmological devices, and market trends. The acquired expertise will allow you to be an active player in the Investigator Initiated Studies programme, as well as support clinical trials for registration of our devices globally. In collaboration with Investigators and/or Clinical Research Organizations you will participate in study design and protocol writing, document creation, results review and interpretation, report writing, as well as support study activities. You will help to develop and execute publication projects according to the publication strategy to generate a publication portfolio on company products.

Your duties
  • Participate in the development of clinical trial designs with internal resources and/or CROs
  • Assist in clinical trial-related processes, such as the planning and execution of clinical studies, including investigator selection, the analysis of potential patient recruitment, the creation of study-related documents (protocols, case report forms, informed consent, clinical trial agreements), organising IRB/EC submissions with follow-through to ensure a successful outcome
  • Clinical review of study data
  • Regulatory submissions to relevant agencies, including CE mark application
  • Conduct all duties in compliance with Good Clinical Practice ICH/GCP and appropriate regulatory requirements
Your qualifications
  • University degree with experience in Medical, Scientific or Clinical Affairs
  • Previous experience implementing, supporting and managing premarket device trials
  • Significant knowledge of clinical research and study design
  • Understanding of statistics, statistical methods, and design of the experiment is a requirement
  • Highly customer-oriented, with excellent communication skills
  • Fluent English and German
  • Willingness to travel during 20 - 30% of your working time
You possess a university degree in Biomedical Sciences, or a master’s degree or a PhD, as well as experience working in a clinical environment in Clinical Affairs or Clinical Research. You understand the medical device or pharmaceutical business modes and market dynamics and the medical device regulatory environment. You look forward to supporting medical and clinical affairs activities with the aim of expanding clinical research and educational grants, establishing medical advisory boards, ensuring ethical and science-based product education materials & communication for healthcare providers. You are solution-oriented and influence your contacts in a tactful, convincing way. Good communication skills in German and business-fluent English round out your profile.
Please call us for a non-binding preliminary discussion or send us your application documents by email. We look forward to getting to know you.
  • Job title
    Clinical Affairs Manager
  • Sector
    Medical Technology / Healthcare
  • Occupational group
    Research / Development / Engineering
  • Region
    Greater Bern
  • Reference number
    3758.BE
  • Your consultant
    Martin Käser
    Martin Käser - martin.kaeser@ems.ch
    Bern
    Neuengasse 39
    CH-3011 Bern
    +41 31 326 23 23
Martin Käser
Martin Käser