Clinical Operations Manager

BiVACOR Inc • Huntington Beach, CA

4d • $118,000 - $154,000 • Onsite

About The Position

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.

Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field
• 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

Nice To Haves

• advanced degree or CRA/CRC certification preferred

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

Benefits

• 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
• A discretionary annual bonus may be available based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level