Senior Clinical Research Operations Manager (m/f/d)

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You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s unforgettable moments.

We offer exceptional career opportunities through market-leading brands from consumer to medical, products and services that keep pushing hearing care forward, and a culture where you can quickly belong and perform at your best.

If you want the freedom to explore, opportunities to grow, and make positive change on people\’s lives through your work, this is the place for you.

Join Sonova. Create sense.

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 a manner compliant with business procedures and relevant regulations.

• 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.

Create impact. Transform lives – sonova.com/careers

Sonova is an equal opportunity employer.

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the marketplace. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.

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