Ziemer Ophthalmic Systems AG
Here you will find our current job offers.

Clinical Affairs Manager (w/m) 80-100%

Tasks

  • Manage all aspects of clinical trials, starting from planning to closeout and reporting
  • Write or contribute to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research-related documents
  • Prepare and submit application dossiers to ECs
  • Interact as an interface between the company and CRO, ensure that CRO activities and timelines are in coordination with regulatory and project requirements, implement and document communication with CRO and sites to ensure project progress
  • Track and report on study progress including site initiation, subject/patient enrollment, monitoring visits and relevant documents
  • Maintain the EDC systemand registry of all study documents
  • Support regulatory affairs in completion of clinical aspects of regulatory applications coupled with international regulatory submissions to appropriate agencies inclusive of CE mark application
  • Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements

Profile

  • M.S. degree in the biomedical sciences or equivalent with four years' experience in medical, scientific or clinical affairs OR Ph.D. with two years' experience working in clinical research
  • Working knowledge of Good Clinical Practices and experience in basic biostatistics
  • Good understanding of medical device or pharmaceutical business modes and market dynamics
  • Self-starter, able to work independently and self-manage time, goals and tasks
  • Team player, willing to work cross-functionally and understand the perspectives of individuals in other departments
  • Ability to travel approximately 20% 
  • Fluent English (C1-C2), good communication skills in German
  • Proficiency on MS-Office-Programms (Excel and PowerPoint)

We offer you an exciting challenge in the growth-oriented market of medical technology. As a committed and proactive personality, you can play a formative role in the future of our dynamic company.

Have we aroused your interest? Then we look forward to receiving your complete online application, which we will of course treat with complete discretion. 

For further information, please contact Mr. Richard Buechi, Director Human Resources, by e-mail or by telephone +41 32 332 71 00. Contact person for subject-related questions is Dr. Olga Grossenbacher, .

For this position we will only consider direct applications (no recruitment agencies).

Apply online

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