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Senior Manager, Clinical Trials

Sonova Group · Santa Clarita, California, United States · 3 days ago
EngineeringFull-time

About the role

The Senior Manager, Clinical Trials is responsible for overseeing advanced phase and pivotal clinical trials for medical devices, adhering to ICH E6 GCP, ISO 14155, FDA, and EU MDR regulations. This role requires strategic planning, decision-making authority, and alignment with business objectives.

Responsibilities

  • Own strategic planning, oversight, and accountability for complex, multi-country clinical trials.

  • Drive clinical program strategy, ensure cross-functional alignment, and deliver high-quality evidence for product registration and clinical claims.

  • Develop and manage global study budgets, timelines, and risk mitigation plans.

  • Build and lead a high-performing team of data managers and scientists.

  • Manage vendor selection and performance, and oversee contract and clinical finance activities.

  • Apply project management skills to plan and execute global clinical trials.

  • Provide strategic financial updates to senior leadership and maintain compliance with regulatory requirements.

Requirements

  • Bachelor’s degree in science/clinical/healthcare field, or equivalent combined education.

  • Advanced degree (MS or equivalent); CCRP, CCRA, or PMP certification preferred.

  • 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.

  • Proven ability to build strong relationships with external partners, CROs, and vendors.

  • In-depth working knowledge of GCP, ICH guidelines, ISO 14155, FDA IDE/PMA regulations, and EU MDR clinical investigation requirements.

  • Experience with MS Office, EDC systems, and CTMS platforms.

Qualifications

  • English Fluency (written and spoken).

  • Minimum 200Mb/sec download and 10Mb/sec upload speed internet connectivity.

Skills

  • Strong analytical, organizational, and adaptability skills.

  • Excellent communication and independent working abilities.

  • Project management skills and proficiency with MS Office.

  • Experience with GCP, ICH guidelines, ISO 14155, FDA IDE/PMA regulations, and EU MDR clinical investigation requirements.

Benefits

  • Medical, dental, and vision coverage.

  • Health Savings, Health Reimbursement, and Flexible Spending/Dependent Care Accounts.

  • TeleHealth options.

  • Company-paid life and AD&D insurance.

  • Tuition reimbursement.

  • Hearing aid discount for employees and family.

  • Short/Long-Term Disability coverage (STD/LTD).

  • Accident/Hospital Indemnity coverage.

  • Legal/ID Theft Assistance.

  • PTO (or sick and vacation time).

  • Paid parental bonding leave.

  • Employee Assistance Program (24/7 mental health support hotline, 5 company paid counseling sessions and more).

  • Internal career growth opportunities.

  • Diversity Day.

  • Paid holidays.

Pay

$131,560 - $164,450.

Schedule

Hybrid 3 days per week.

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