Sonova Group

Clinical Operations Manager

Sonova Group

full-time

Posted on:

Origin:  • 🇺🇸 United States • California

Visit company website
✨ AI Apply
Manual Apply

Salary

💰 $94,400 - $141,600 per year

Job Level

Mid-LevelSenior

About the role

  • 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.

Requirements

  • 5 years of experience with clinical trials
  • Bachelor’s degree in a medically related discipline
  • Experience with active implantable or Class 3 medical devices
  • Training in clinical trial management
  • Training in electronic data management
  • Experience with regulatory requirements for clinical trials (FDA, ISO)
  • IT Skills: Expertise with standard MS Office Software