Clinical Operations Manager

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:

• Bachelor's degree in a medically related discipline

• Post-baccalaureate degree preffered

• Training in clinical trial management or electronic data management desireable

• 5 years of experience with clinical trials
• Prior experience with active implantable or Class 3 medical devices a bonus

• Understanding of regulations for clinical trial conduct (FDA, ISO)
• Experience with new product submission under MDR preferred

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!

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 $94,400/yr - $141,600/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.