Clinical Operations Manager

BiVACOR Inc; Huntington Beach (CA); On-site; USD 118,000 - 154,000; Full time

Benefits offered by this job

401(k) with company matching

Medical, dental, and vision insurance

Generous paid time off

Job summary

BiVACOR Inc in Huntington Beach is looking for a Clinical Operations Manager to lead logistics for clinical studies. You'll ensure compliance and operational readiness for the world’s first Total Artificial Heart clinical trials.

The ideal candidate will have 3-5 years of clinical operations experience, a Bachelor’s degree in Life Sciences, and a solid understanding of GCP and FDA regulations. A competitive salary and benefits package is offered.

Qualifications

• 3–5+ years of clinical operations or clinical trial management experience.
• Solid understanding of ICH-GCP and FDA IDE regulations.
• Experience managing regulatory binders and investigational logistics.

Responsibilities

• Oversee operational logistics for clinical study activities at sites.
• Maintain site qualification documentation and operational SOPs.
• Coordinate supply chain activities related to clinical devices.

Skills

Clinical operations experience

Clinical trial management

Regulatory compliance

Stakeholder management

Attention to detail

Education

Bachelor’s degree in Life Sciences or related field

Advanced degree or CRA/CRC certification

Tools

Clinical trial management systems (CTMS)

Electronic trial master file (eTMF) platforms

Job description

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.

About the Role

This is a high-impact, cross‑functional role at the heart of BiVACOR’s clinical program, where your operational expertise will directly shape the success of our first‑in‑human and pivotal clinical studies. As Clinical Operations Manager, you will be the organizational backbone of site‑level activity, ensuring every participating center is prepared, compliant, and ready to support patients receiving the world’s first Total Artificial Heart. You will bring meticulous attention to detail, a deep understanding of clinical trial operations, and a collaborative approach that keeps complex, multi‑site programs on track.

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
• Coordinate supply chain activities related to clinical device inventory and investigational materials
• Support site initiation visits and ensure operational readiness prior to patient enrolment
• Liaise with 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
• 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
• Can‑do attitude — highly organized — strong cross‑functional communication and stakeholder management skills
• 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

This role may be based at BiVACOR’s Huntington Beach headquarters. 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.

Apply today and be part of something extraordinary.

BiVACOR is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.