Clinical Operations Manager

Clinical Operations Manager

Job Overview

Who we are

In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we – through our core business brands Phonak, Unitron, Hansaton, Advanced Bionics and AudioNova – develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.

Valencia (CA), United States

Clinical Operations Manager

Covid Protocol:
Upholding the company values is extremely important to Sonova, we take the health and safety of our employees, patients, customers and their families very seriously. To that end, we have concluded that the best way to ensure the safety of these individuals is to mandate that all our newly hired employees be fully vaccinated for COVID-19. Therefore, when considering whether to apply for this position, please know that in order to become employed by Sonova (if otherwise eligible), you must provide satisfactory proof, such as a vaccine card or other documentation, that you are fully vaccinated for COVID-19. You will not be required to provide this proof unless and until you receive a formal job offer from Sonova. Please also know that Sonova will provide accommodations to qualified individuals who cannot receive the COVID-19 vaccination because of a sincerely held religious belief or due to a medical issue or pregnancy.
Overview
The Senior Clinical Research Operations Manager is responsible for leadership of clinical trials to support regulatory approval of new medical devices. These leadership responsibilities include study planning, budgeting, project management, supervision of study staff, and reporting. The Manager is responsible for ensuring clinical trials operate manner compliant with business procedures and international regulations. The Manager is responsible for the work prioritization and allocation of Advanced Bionics’ study staff.
What you’ll do:
  • 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
Travel Requirement: Up to 30% travel to study centers, professional conferences and corporate events
What you bring to the team:
Education
  • Bachelor’s degree in a medically related discipline
Nice to Have
  • Post-baccalaureate degree
Further Education
  • Training in clinical trial management
Nice to Have
  • Training in electronic data management
Work Experience
  • 10 years of experience with clinical trials
Nice to Have
  • Experience with active implantable or Class 3 medical devices
Personal Competencies
  • Solution-oriented mindset
  • Open to continuous improvement
Social Competencies
  • Exceptional spoken and written communication ability
  • Highly collaborative
Professional Competencies
  • Expert understanding of regulations for clinical trial conduct (FDA, ISO)
Nice to Have
  • Experience with new product submission under MDR
Language(s) / Level
  • English Fluency
IT skills
  • Expertise with standard MS Office software
Nice to Have
  • Familiarity with electronic data systems
Our offer:
  • Exciting and challenging work environment
  • Comprehensive benefits package
  • Training and development opportunities – we believe every employee deserves a development plan. Come, learn, and grow with us!
Don’t meet all the criteria? If you’re willing to go all in and learn we’d love to hear from you!
We love to work with great people and strongly believe that a diverse team makes us better. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of race, color, creed/religion, sex, sexual orientation, marital status, age, mental or physical disability.
We thank all applicants in advance; however only individuals selected for an interview will be contacted. All applications will be kept confidential. Sonova is an equal opportunity employer. Applicants who require reasonable accommodation to complete the application and/or interview process should notify the Director, Human Resources.

 

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