Valencia, CA (Hybrid 3 days)

The Senior Manager, Clinical Trials is the end-to-end owner of Advanced Bionics' late-phase and pivotal studies, accountable for strategy, protocol authorship, timelines, budget, and regulatory readiness across FDA and EU MDR. As the primary clinical subject matter expert, this role drives clinical program strategy, ensures cross-functional alignment, and delivers high-quality evidence for product registration and clinical claims.

Responsibilities:

• Own the strategic planning, oversight, and accountability for complex, multi-country clinical trials for medical devices in compliance with ICH E6 GCP, ISO 14155, FDA, and EU MDR regulations, within budget and timelines
• Serve as the primary clinical subject matter expert and single study owner - holding full decision-making authority across all trial activities, driving the strategic direction of clinical development programs, and ensuring alignment with business objectives
• Lead and develop key study documents including protocols, ICFs, EDC specifications, statistical analysis plans, and study reports; ensure high-quality data collection, statistical integrity, and timely reporting of results
• Hold accountability for global study delivery by directing Clinical Operations, aligning Clinical Evaluation, Medical Affairs, and the Clinical Development team to ensure consistent, compliant, and strategically aligned execution
• Lead strategic vendor selection and governance globally; oversee vendor performance against study requirements, escalating issues and driving accountability to ensure high-quality deliverables
• Apply project management skills, processes, and tools to plan and execute local, regional, and global clinical trials at Advanced Bionics, including:
  • Scope - Define and approve trial scope; oversee change control processes and hold the cross-functional team accountable to deliverables.
  • Timeline - Develop and manage global enrollment strategy and country allocation; own timelines from start-up through CSR production and drive contingency plans as needed.
  • Risk - Oversee trial-level risk identification and escalation; approve the integrated mitigation and contingency plan drawing on scientific, operational, and regional expertise.
  • Budget - Develop, own, and manage global trial budgets; ensure delivery within approved financial parameters and provide strategic financial updates to senior leadership.
• Build and lead a high-performing team of data managers and scientists; establish data management capabilities, drive evidence generation to support product registration and clinical claims, and lead the build-out of Global Clinical Trials infrastructure including SOPs, systems, governance, and continuous improvement
• 10-20% travel to conferences and study-related activities as required.

More about you:

• Bachelor's degree in science/clinical/healthcare field, or equivalent combined education
• Advanced degree (MS or equivalent); CCRP, CCRA, or PMP certification a plus
• 8+ years of strong hands-on experience leading large, complex Phase 3 or pivotal clinical trials in the US and internationally; or equivalent combination of training and experience
• Analytical, organized, adaptable; strong communication and ability to work independently in a matrixed environment.
• Proven ability to build strong relationships with external partners, CROs, and vendors; demonstrated experience managing contracts and clinical finance activities across global studies; strong track record in timeline and budget management for complex, multi-country clinical trials
• In-depth working knowledge of GCP, ICH guidelines, ISO 14155, FDA IDE/PMA regulations, and EU MDR clinical investigation requirements; experience with multi-jurisdictional regulatory submissions and international EC/IRB processes
• Proficiency with MS Office; experience with EDC systems and CTMS platforms
• English Fluency (written and spoken)

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 mailto:[redacted]

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: $131,560 - $164,450. This role is also bonus eligible.

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.