Senior Clinical Research Manager - Cardiac IDE Studies

BiVACOR Inc; Huntington Beach (CA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

401(k) with company matching

Medical, dental, and vision insurance

Health Savings Account (HSA) & Flexible Spending Account (FSA)

Life insurance & Employee Assistance Program

Generous paid time off

Job summary

BiVACOR Inc is seeking a Senior Clinical Research Manager to lead US IDE study operations at their Huntington Beach headquarters. In this crucial role, you will oversee all clinical trial activities, ensuring compliance with FDA regulations while guiding a team of professionals focused on revolutionizing cardiac care with a total artificial heart technology.

The ideal candidate brings extensive clinical research experience, strong leadership skills, and a comprehensive understanding of regulatory requirements. We offer competitive compensation packages and a supportive benefits structure.

Qualifications

• 5+ years of clinical research experience in a medical device or pharmaceutical environment.
• 3+ years in a management or team leadership role.
• Extensive experience managing US IDE studies.

Responsibilities

• Manage US IDE clinical study operations including site activation and monitoring.
• Lead and develop a team of Clinical Research Specialists and Associates.
• Ensure GCP compliance and protocol adherence across US sites.

Skills

Clinical research experience

Leadership skills

Regulatory knowledge (FDA)

Data interpretation

Communication skills

Education

Bachelor’s in Life Sciences, Nursing, Biomedical Engineering

Advanced degree preferred

Job description

BiVACOR Inc is seeking a Senior Clinical Research Manager to lead US IDE study operations at their Huntington Beach headquarters. In this crucial role, you will oversee all clinical trial activities, ensuring compliance with FDA regulations while guiding a team of professionals focused on revolutionizing cardiac care with a total artificial heart technology.

The ideal candidate brings extensive clinical research experience, strong leadership skills, and a comprehensive understanding of regulatory requirements. We offer competitive compensation packages and a supportive benefits structure.