Clinical Operations Manager
Clinical Operations Manager
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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.
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.
Travelling Requirement: Up to 30% travel to study centers professional conferences and corporate events.
More about you:
Education
- Bachelors degree in a medically related discipline
Nice to Have
- Post-baccalaureate degree
Further Education
- Training in clinical trial management
Nice to Have
- Training in electronic data management
Work Experience
- 5 years of experience with clinical trials
Nice to Have
- Experience with active implantable or Class 3 medical devices
Personal Competencies
- Solution oriented mindset
Nice to Have
- Open to continuous improvement
Social Competencies
- Exceptional spoken and written communication ability
Nice to Have
- Highly collaborative
Professional Competencies
- Expert understanding of regulations for clinical trial conduct (FDA ISO)
Nice to Have
- Experience with ne product submission under MDR
Language(s)/ Level
- English/ Fluent
IT Skills:
- Expertise with standard MS Office Software
Nice to Have
- 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
Dont meet all the criteria If youre willing to go allin and learn wed 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.
This roles pay range is between $94400/yr - $141600/yr (based on location). This role is also eligible for bonus.
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.
Required Experience:
Manager
Employment Type
Full-Time
