Clinical Operations Manager
About the role
Help Us Build the Future of the Human Heart. At BiVACOR, we’re developing the world’s most advanced total artificial heart, a technology capable of saving millions of lives around the world. We’re a team united by purpose, working on something truly unprecedented. Every site you prepare, every milestone you track, and every compliance requirement you uphold plays a direct role in giving patients another shot at life. If that’s the kind of work that gets you out of bed in the morning, we think you belong here.
Key Responsibilities
- Oversee day-to-day operational logistics for clinical study activities at participating sites
- Maintain site qualification documentation, essential regulatory binders, and operational SOPs
- Track site-level operational milestones and flag deviations
- Cook up supply chain activities related to clinical device inventory and investigational materials
- Serve as the liaison between clinical research and regulatory affairs on site-level compliance requirements
What You Bring
- Bachelor’s degree in Life Sciences, Health Sciences, or a related field; advanced degree or CRA/CRC certification preferred
- 3–5+ years of clinical operations, clinical trial management, or site management experience in a medical device or pharmaceutical environment
- A solid understanding of ICH-GCP, FDA IDE regulations, and essential document requirements for investigational device studies
- Experience managing regulatory binders, site qualification documentation, and investigational supply logistics
- Proficiency with clinical trial management systems (CTMS) and electronic trial master file (eTMF) platforms
- A can-do attitude — highly organized — strong cross-functional communication and stakeholder management skills
- A willingness to travel to clinical sites as required; flexibility to support BiVACOR as our program scales
What We Offer
- BiVACOR offers a competitive compensation package and comprehensive benefits, including:
- 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
The expected salary range for this position based in Huntington Beach, California is $118,000 to $154,000. Actual compensation will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for the benefits detailed at the link provided below.
Relocation benefits are not available for this posting.