What are the responsibilities and job description for the Clinical Operations Manager position at Sonova Group?
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.
Valencia, CA – Hybrid
Clinical Operations Manager
The Senior Clinical Research Operations Manager is responsible for leadership of clinical trials to support regulatory approval of new medical devices. These leadership responsibilities include study planning, budgeting, project management, supervision of study staff, and reporting. The Manager is responsible for ensuring clinical trials operate in a manner compliant with business procedures and international regulations. The Manager is responsible for the work prioritization and allocation of Advanced Bionics’ study staff.
Responsibilities:
More about you:
Education
Don't meet all the criteria? If you’re willing to go all in and learn we'd love to hear from you!
What we offer:
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.
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 market place. 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.
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.
Valencia, CA – Hybrid
Clinical Operations Manager
The Senior Clinical Research Operations Manager is responsible for leadership of clinical trials to support regulatory approval of new medical devices. These leadership responsibilities include study planning, budgeting, project management, supervision of study staff, and reporting. The Manager is responsible for ensuring clinical trials operate in a manner compliant with business procedures and international regulations. The Manager is responsible for the work prioritization and allocation of Advanced Bionics’ study staff.
Responsibilities:
- Ability to effectively plan, lead, and close feasibility and pivotal trials
- Expert knowledge of regulatory requirements for clinical trials
- Complete site selection and define recruitment strategies, including risk analysis and mitigation
- Manage study budgets and timelines
- Complete vendor selection and management
- Oversight of study staff work allocation and site compliance
- Manage the development of standardized work instructions and operating procedures
- Provide oversight for Trial Master File development, maintenance, and reconciliation
- Responsible for reviewing study documents, (e.g. protocols, clinical study reports, Manual of Operations, reference guides).
- Collaborate with data management and product development functions
- Other duties as assigned.
More about you:
Education
- Bachelor’s degree in a medically related discipline
- Post-baccalaureate degree
- Training in clinical trial management
- Training in electronic data management
- 5 years of experience with clinical trials
- Experience with active implantable or Class 3 medical devices
- Solution oriented mindset
- Open to continuous improvement
- Exceptional spoken and written communication ability
- Highly collaborative
- Expert understanding of regulations for clinical trial conduct (FDA, ISO)
- Experience with ne product submission under MDR
- English/ Fluent
- Expertise with standard MS Office Software
- Familiarity with electronic data systems
Don't meet all the criteria? If you’re willing to go all in and learn we'd love to hear from you!
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.
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.
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 market place. 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.
Salary : $94,400 - $141,600
