Clinical Trial Manager Audiology
Job Summary
Clinical Trial Manager Audiology temporary position
Oticon Medical BAHS specializes in developing producing and distributing advanced bone-anchored hearing systems including long-term implants sound processors software and surgical tools. We are a global leader in hearing solutions and we are currently looking for a temporary Clinical Trial Manager with Audiological background to join our global Clinical Affairs team in Gothenburg Sisjön. The position is fixed-term employment valid for 11 months starting from August 1st or as agreed.
As Clinical Trial Manager Audiology at Oticon Medical you play a key role in delivering clinical evidence and expertise across the organization. Your audiological background and know-how will contribute to our product development journey and the strategic direction for the company. You drive clinical investigations of our products and provide essential insights throughout development and the product life cycle. The role entails operational responsibilities for clinical study planning study execution and reporting. You are a part of the global Clinical Affairs Team collaborating closely with R&D QA/RA Marketing and Sales while also building strong relationships with external clinicians and researchers.
Key responsibilities
Planning and execution of clinical trials for Oticon Medical hearing solutions.
Drive submissions and correspondence with ethical committee and competent authorities
Complete documentation for clinical trials according to regulations
Secure high data quality by relevant monitoring activities
Build and maintain a study database
Analyze summarize and disseminate clinical trial data
Contribute to further improvements in internal procedures for clinical trials
Act as a subject matter expert in audiology and support colleagues with study design decisions choice of hearing outcomes and clinical know-how.
Your profile will guide the exact tasks you will work with and the job will vary stretching from strategic decisions to hands-on execution of clinical trials.
You can expect 15-30 days of business travel per year with variation depending on project and phase.
Your profile: Ideally you are a trained Audiologist and hold a university degree in Audiology Medicine Life Science or similar field with operational experience from working with clinical trials of medical devices. Specific know-how around study design execution and result dissemination from both pre- and post-market clinical trials are meriting as well as a good understanding of relevant steering regulations (e.g. ISO14155 Good Clinical Practice).
You are fluent in English and have strong communication skills. You have the ability to build strong relationships and collaborate with researchers and healthcare professionals. You have a pragmatic andcommercial mindset and combine a scientific approach with business awareness are result-oriented and pay attention to both detail and the bigger picture.
Why Oticon Medical
At our Office in Sisjön we are a team of around 70 employees spanning R&D marketing operations QA/RA and project management. Collaboration is our greatest strength as we believe the best results come from a team-driven foster a culture of trust openness respect and kindness. We also offer flexible working conditions and prioritize work-life balance. By joining our growing global company you will directly contribute to enhancing the lives of individuals worldwide.
Interested
Submit your application and CV through our online recruitment system. Please note that we do not accept applications via email. Applications will be reviewed continuously and the recruitment process may close before the stated deadline of May 20th.
We look forward to hearing from you!
Required Experience:
Manager
About Company
Leading in hearing healthcare Demant is the only company in the world that covers all areas of hearing healthcare, from hearing devices and hearing implants to diagnostic instruments and professional hearing care, and we harvest significant synergies from this unique position and exp ... View more