Stuttgart-Fellbach, Germany
Senior Clinical Research Operations Manager (m/f/d)
Remote working possible (within Germany)
We are looking for a Clinical Affairs team member responsible for the operation of clinical studies, which include the project management of clinical studies, handling of investigational devices, and communication with ethics boards, authorities and notified bodies.
You will help to lead project planning, budgeting, resource tracking, and status reporting. Further, you will ensure that essential study documents are maintained, and the clinical study conduct is completed in manner compliant with business procedures and relevant regulations.
Our Offer for your Engagement:
- Exciting and challenging work environment
- Collaborative culture; atmosphere of mutual trust in a highly motivated, international team
- Permanent contract, Flexible working times, JobRad, attractive pay according to achievement, 30 days annual holiday
- Training and development opportunities – we believe every employee deserves a development plan. Come, learn, and grow with us
- A company that values diversity and inclusion
- You help to improve the quality of life of millions of people with hearing loss!
Main tasks and responsibilities:
- Leading the operational planning, tracking, and closure of clinical studies for medical devices
- Leading collaboration with cross functional teams to secure support necessary for clinical studies
- Proactively engaging with clinical and business leadership to report on study status and, when necessary, presents scenarios for maintaining on-time and on-budget study progress
- Responsible for preparing and reviewing essential study documents while ensures that clinical studies are conducted in compliance with relevant regulatory requirements and Sonova relevant procedures
- Ensuring on time submission to and communication with ethics committees and authorities
- Provides oversight for Trial Master File development, maintenance, and reconciliation through onsite and remote monitoring
Your profile:
- Bachelor’s degree in a medically related discipline and further training in clinical study management
- 5+ years of experience with clinical studies including an expert understanding of regulations for clinical study conduct (e.g. ISO 14155; EU Medical Device Regulation)
- Exceptional spoken and written communication ability (English and German) to build rapport with collaborators from different cultural and educational backgrounds
- Willingness to travel (up to 10%) to clinical study centers, conferences, corporate events
- Solution-oriented mindset, open to continuous improvement,
- IT skills: Microsoft Office, ideally familiar with project management and electronic data capturing systems
In return, we offer an exciting and challenging position with great potential for personal development, with a unique organization in a fascinating and fast-growing medical industry. If you want to work in an enthusiastic, motivated team and help launch the hearing aids of the future then send us your online application in English. We favor disabled applicants over non-disabled applicants if they have the same qualification.
For this vacancy only direct applications will be considered.
Sonova Deutschland
Max-Eyth-Str. 20
70736 Fellbach
+49 711 51070 133
Create impact. Transform lives – sonova.com/careers