About the RoleThis 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 OfferBiVACOR 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.
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