Clinical Operations Manager

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, through our core business brands – Advanced Bionics, Audiological Care, Phonak, Sennheiser (under license) and Unitron – we develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.

 

Valencia, CA – Hybrid 

Clinical Operations Manager

 

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 in a manner compliant with business procedures and international regulations. The Manager is responsible for the work prioritization and allocation of Advanced Bionics’ study staff.

 

Responsibilities:

• 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.

 

More about you:

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

• 5 years of experience with clinical trials

Nice to Have

• Experience with active implantable or Class 3 medical devices

 

 

Personal Competencies

• Solution oriented mindset

Nice to Have

• Open to continuous improvement

 

 

Social Competencies

• Exceptional spoken and written communication ability

Nice to Have

• Highly collaborative

 

 

Professional Competencies

• Expert understanding of regulations for clinical trial conduct (FDA, ISO)

Nice to Have

• Experience with ne product submission under MDR

 

 

Language(s)/ Level

• English/ Fluent

 

 

 

IT Skills:

• Expertise with standard MS Office Software

Nice to Have

• Familiarity with electronic data systems