Senior Manager, Clinical Trials

Sonova Group

Valencia, CA, United States
Base: $131,560 - $164,450; bonus: eligible; benefi...
On-site
8+ years leading phase 3 pivotal trials
Expertise in ich e6 gcp and iso 14155
Fda ide/pma and eu mdr regulatory knowledge
This role serves as the end-to-end owner of Advanced Bionics' late-phase and pivotal clinical studies, accountable for strategy, protocol authorship, and regulatory readiness across FDA and EU MDR

Job Summary

  • This role serves as the end-to-end owner of Advanced Bionics' late-phase and pivotal clinical studies, accountable for strategy, protocol authorship, and regulatory readiness across FDA and EU MDR.
  • The successful candidate will lead a high-performing team, develop key study documents, and drive evidence generation to support product registration and clinical claims.
  • Sonova offers a comprehensive benefits package including medical, dental, vision, 401k match, paid parental leave, and robust internal career growth opportunities.

Matching Summary

This role serves as the end-to-end owner of Advanced Bionics' late-phase and pivotal clinical studies, accountable for strategy, protocol authorship, and regulatory readiness across FDA and EU MDR.

Salary

Base: $131,560 - $164,450; Bonus: Eligible; Benefits: Medical, dental, vision, 401k match, PTO, parental leave

Skills & Requirements

Must-have

  • 8+ years leading Phase 3 pivotal trials
  • Expertise in ICH E6 GCP and ISO 14155
  • FDA IDE/PMA and EU MDR regulatory knowledge
  • Global multi-country trial management
  • Budget and timeline ownership for complex studies

Nice-to-have

  • CCRP or CCRA certification preferred
  • PMP certification a plus
  • Experience building clinical infrastructure
  • Strong vendor selection and governance skills
  • Ability to work independently in matrixed environment

Key Requirements

  • Bachelor's degree in science/clinical/healthcare field
  • Advanced degree (MS) preferred
  • Minimum 8 years hands-on experience with Phase 3 trials
  • English fluency required
  • 200Mb/sec internet speed for hybrid work

Work Rights

Not specified

Tailored Resume

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