Clinical Research Operations Manager

at Phonak in Aurora, Illinois, United States

Job Description

Who we are
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 lives through your work, this is the place for you.
Join Sonova. Create sense.

Aurora (IL), United States

Clinical Research Operations Manager

154003

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 allin 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... For full info follow application link.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.