Clinical Affairs Manager (f/m/d)

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 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

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.

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)