Clinical Data Operations Manager

Sonova Group

Valencia, CA, United States
Base: $94,400pyr - $120,000.00pyr; bonus/equity: b...
On-site
Clinical data management
Regulatory submissions
Data integrity
Sonova Group is seeking a Clinical Data Operations Manager in Valencia, CA, responsible for overseeing clinical data management and ensuring compliance with regulatory standards. The role requires extensive experience in clinical data management, particularly in an FDA-regulated environment, and offers a supportive work culture that prioritizes employee well-being

Job Summary

  • Responsible for overseeing the collection, analysis, and interpretation of clinical data to support regulatory submissions, post-market surveillance, and evidence generation.
  • Develop, maintain, and enforce standard operating procedures (SOPs) and work instructions for clinical data management.
  • At Sonova, we prioritize the well-being of our employees and foster an inclusive environment that promotes engagement and collaboration.

Matching Summary

Match Score: 85

Sonova Group is seeking a Clinical Data Operations Manager in Valencia, CA, responsible for overseeing clinical data management and ensuring compliance with regulatory standards. The role requires extensive experience in clinical data management, particularly in an FDA-regulated environment, and offers a supportive work culture that prioritizes employee well-being.

Salary

Base: $94,400/yr - $120,000.00/yr; Bonus/Equity: bonus eligible; Benefits: Medical, dental, vision, 401k with match, PTO, life/disability insurance, EAP

Skills & Requirements

Must-have

  • clinical data management
  • regulatory submissions
  • data integrity
  • FDA regulations
  • GCP compliance
  • EDC systems

Nice-to-have

  • risk-based monitoring
  • centralized statistical monitoring
  • data visualization tools
  • employee experience analysis

Key Requirements

  • Bachelor’s Degree in a related field
  • 5-7 years extensive experience in clinical data management
  • Experience in an FDA-regulated environment
  • Prior experience with international regulatory frameworks preferred
  • Prior exposure to medical device trials
  • Hands-on experience with advanced EDC and CTMS systems
  • Certification in Clinical Data Management, Project Management, or Clinical Research preferred

Work Rights

Not specified

Tailored Resume

Cover Letter