Job Overview
Who we are
In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we – through our core business brands Phonak, Unitron, Hansaton, Advanced Bionics and AudioNova – develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.
Clinical Operations Manager
- Ability to effectively plan, lead, and close feasibility and pivotal trials
- Expert knowledge of regulatory requirements for clinical trials
- Complete site selection and define recruitment strategies, including risk analysis and mitigation
- Manage study budgets and timelines
- Complete vendor selection and management
- Oversight of study staff work allocation and site compliance
- Manage the development of standardized work instructions and operating procedures
- Provide oversight for Trial Master File development, maintenance, and reconciliation
- Responsible for reviewing study documents, (e.g. protocols, clinical study reports, Manual of Operations, reference guides).
- Collaborate with data management and product development functions
- Bachelor’s degree in a medically related discipline
- Post-baccalaureate degree
- Training in clinical trial management
- Training in electronic data management
- 10 years of experience with clinical trials
- Experience with active implantable or Class 3 medical devices
- Solution-oriented mindset
- Open to continuous improvement
- Exceptional spoken and written communication ability
- Highly collaborative
- Expert understanding of regulations for clinical trial conduct (FDA, ISO)
- Experience with new product submission under MDR
- English Fluency
- Expertise with standard MS Office software
- Familiarity with electronic data systems
- Exciting and challenging work environment
- Comprehensive benefits package
- Training and development opportunities – we believe every employee deserves a development plan. Come, learn, and grow with us!