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- Aufgaben: Lead and manage clinical studies for innovative medical devices.
- Arbeitgeber: Join a diverse team dedicated to improving lives through advanced hearing solutions.
- Mitarbeitervorteile: Enjoy flexible working hours, 30 days of vacation, and opportunities for personal growth.
- Warum dieser Job: Be part of a collaborative culture that values trust and innovation in the medical field.
- Gewünschte Qualifikationen: Bachelor's degree in a medical field and 5+ years of clinical study experience required.
- Andere Informationen: Remote work possible within Germany; direct applications only.
Das voraussichtliche Gehalt liegt zwischen 54000 - 84000 € pro Jahr.
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 a 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 ensuring 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
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Senior Clinical Research Operations Manager (m/f/d) Arbeitgeber: Sonova
Kontaktperson:
Sonova HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Senior Clinical Research Operations Manager (m/f/d)
✨Tip Number 1
Make sure to highlight your experience with clinical studies and your understanding of relevant regulations like ISO 14155 and the EU Medical Device Regulation. This will show us that you have the expertise we’re looking for.
✨Tip Number 2
Demonstrate your exceptional communication skills by preparing to discuss how you've successfully collaborated with cross-functional teams in the past. We value strong interpersonal skills, especially in a diverse environment.
✨Tip Number 3
Be ready to share examples of how you've managed project planning and budgeting in previous roles. We want to see your solution-oriented mindset and how you’ve ensured projects stay on time and within budget.
✨Tip Number 4
Familiarize yourself with our company culture and values, especially regarding diversity and inclusion. Showing that you align with our mission to improve the quality of life for people with hearing loss can set you apart.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Senior Clinical Research Operations Manager (m/f/d)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Clinical Research Operations Manager position. Understand the key responsibilities and required qualifications, as this will help you tailor your application effectively.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 5+ years of experience with clinical studies. Be specific about your project management skills, knowledge of regulations, and any relevant training in clinical study management.
Showcase Communication Skills: Since exceptional spoken and written communication abilities are crucial for this role, provide examples in your application that demonstrate your proficiency in both English and German. Mention any experiences where you successfully collaborated with diverse teams.
Tailor Your Application: Customize your cover letter to reflect your understanding of the company's mission and values. Express your enthusiasm for contributing to improving the quality of life for people with hearing loss, and mention how your skills align with their needs.
Wie du dich auf ein Vorstellungsgespräch bei Sonova vorbereitest
✨Showcase Your Project Management Skills
Be prepared to discuss your experience in leading clinical studies, including specific examples of project management, budgeting, and resource tracking. Highlight how you have successfully managed timelines and budgets in previous roles.
✨Demonstrate Regulatory Knowledge
Familiarize yourself with relevant regulations such as ISO 14155 and the EU Medical Device Regulation. Be ready to explain how you ensure compliance in clinical study conduct and how you handle submissions to ethics committees and authorities.
✨Communicate Effectively
Since exceptional communication skills are crucial for this role, practice articulating your thoughts clearly in both English and German. Prepare to discuss how you build rapport with cross-functional teams and stakeholders from diverse backgrounds.
✨Emphasize Continuous Improvement
Adopt a solution-oriented mindset and be ready to share examples of how you've implemented improvements in past projects. Discuss your willingness to learn and adapt, which aligns with the company's values of development and growth.
