Clinical Affairs Manager (f/m/d) 80-100%

High-Tech. Family-focused. Global.

We aim to enhance the lives of millions. Driven by our passion for innovation, we tirelessly develop cutting-edge products and services in ophthalmology. Become a part of the Ziemer Group's 25-year legacy and contribute to our ever-expanding team. Why Ziemer

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
• Design, develop and validate EDC sytem (based on existing web-based platform) and eCRFs for the studies
• Prepare and submit application dossiers to ECs and CAs, as applicable
• 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 system and 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 Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements

Profile

• 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
• Team player, willing to work cross-functionally and understand the perspectives of individuals in other departments
• Self-starter, able to work independently and self-manage time, goals and tasks
• Ability to travel approximately 20%
• Fluent English (C1 – C2), good communication skills in German as an advantage
• Proficiency in MS-Office-Programs (Excel and PowerPoint)

We offer you an exciting challenge in the growth-orientated medical technology market. As a committed and proactive personality, you can play a key role in shaping the future of our dynamic company. Have we aroused your interest? Then we look forward to receiving your complete online application (including a letter of motivation).

For further information, please contact Mr Richard Büchi, Director Human Resources, or tel. 032 332 71 00.
If you have any technical questions, please contact Dr Olga Grossenbacher, Director Clinical & Medical Affairs, .

Arbeitsort