Clinical Research Operations Manager

Job description

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, through our core business brands – Advanced Bionics, Audiological Care, Phonak, Sennheiser (under license) and Unitron – we develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.
Aurora, IL
Clinical Research Operations Manager  
Clinical Research Operations Managers are responsible for the project management of clinical studies and related clinical projects. They are an essential partner in project planning, budgeting, project management, and status reporting. The Manager is responsible for ensuring essential study documents are maintained and study conduct is completed in manner compliant with business procedures and relevant regulations.
Responsibilities:
• Contributes to the planning, tracking, and closure of clinical studies
• Monitors and reports on clinical study budgets and timelines
• Ensures that clinical studies are conducted in compliance with relevant regulatory requirements
• Provides oversight of site and staff compliance to study and Sonova procedures
• Ensures on time submission to and communication with ethical review committees and institutional review boards
• Provides oversight for Trial Master File development, maintenance, and reconciliation through onsite and remote monitoring
• Responsible for preparing and reviewing essential study documents, (e.g. , investigator brochure, contracts, data use agreements, quotes, invoices, etc).
• Responsible for registration of studies with appropriate public databases
• Manage the development of relevant work instructions and operating procedures
• Engages with clinical and business leadership to report on study status and, when necessary, presents scenarios for maintaining on-time and on-budget study progress
• Proactively identifies and mitigates risks to project timeline or budget
• Collaborate with cross functional teams to identify inputs and documentation necessary for support of clinical studies and projects
* 10% travel to study centers, professional conferences, and corporate events is expected


More about you:
* Bachelor’s degree in a medically related discipline

* Training in clinical study management

* Training in audiology or hearing science

* Training in electronic data management

* 3 years of experience with clinical studies

* Solution-oriented mindset

* Exceptional spoken and written communication ability
* Ability to build rapport with collaborators from different cultural and educational backgrounds.
* Understanding of regulations for clinical study conduct (e.g. FDA, ISO, NMPA)

* English fluency

* Expertise with standard MS Office software

* Experience with multi-disciplinary collaboration

* Experience with new product submission under MDR

* Familiarity with electronic data systems


A minimum of 200Mb/sec download and 10Mb/sec upload speed internet connectivity is required to support any remote/hybrid employee functionality at Sonova
Don't meet all the criteria?  If you’re willing to go all in and learn we'd love to hear from you! 

We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone please contact  

 What we offer:
* Medical, dental and vision coverage*
* Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
* TeleHealth options
* 401k plan with company match*
* Company paid life/ad&d insurance Additional supplemental life/ad&d coverage available

* Company paid Short/Long-Term Disability coverage (STD/LTD) STD LTD Buy-ups available

* Accident/Hospital Indemnity coverage
* Legal/ID Theft Assistance
* PTO (or sick and vacation time), floating Diversity Day, & paid holidays*
* Paid parental bonding leave
* Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more)
* Robust Internal Career Growth opportunities
* Tuition reimbursement
* Hearing aid discount for employees and family
* Internal social recognition platform
* D&I focused: D&I council and employee resource groups
*Plan rules/offerings dependent upon group Company/location.

This role's pay range is between: $128k -138k  . This role is also commission eligible/bonus eligible. *(based on location and experience)

How we work:
At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team-customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.

Desired profile

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About Sonova AG

Sonova AG