Lead Clinical Operations Manager, Medical Devices

Extheramedical Llc; Martinez (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

Extheramedical Llc in California is seeking a Clinical Operations Manager to oversee clinical trials for medical devices. This role demands leadership in managing clinical project operations while ensuring compliance with regulatory standards.

The ideal candidate will have a minimum of 7 years' experience in clinical project management and a solid understanding of ICH guidelines. Responsibilities include managing clinical trials, directing protocol development, and ensuring regulatory compliance.

Qualifications

• 7+ years of clinical project management experience in clinical trials.
• Solid understanding of ICH guidelines and Good Clinical Practices.
• Experience interacting with regulators including the FDA.

Responsibilities

• Manage sponsor-led clinical trials for medical devices.
• Direct protocol development and ensure compliance with regulations.
• Oversee the preparation and submission of regulatory documents.

Skills

Clinical project management

Regulatory compliance

Team leadership

Communication skills

Education

Bachelor’s degree in life science

Job description

Extheramedical Llc in California is seeking a Clinical Operations Manager to oversee clinical trials for medical devices. This role demands leadership in managing clinical project operations while ensuring compliance with regulatory standards.

The ideal candidate will have a minimum of 7 years' experience in clinical project management and a solid understanding of ICH guidelines. Responsibilities include managing clinical trials, directing protocol development, and ensuring regulatory compliance.