Clinical Operations Manager

Join BiVACOR to Build the Future of the Human HeartAt 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 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 ResponsibilitiesOversee day-to-day operational logistics for clinical study activities at participating sitesMaintain site qualification documentation, essential regulatory binders, and operational SOPsTrack site-level operational milestones and flag deviationsCoordinate supply chain activities related to clinical device inventory and investigational materialsSupport site initiation visits and ensure operational readiness prior to patient enrolmentLiaise with clinical research and regulatory affairs on site-level compliance requirementsWhat You BringBachelor's degree in Life Sciences, Health Sciences, or a related field; advanced degree or CRA/CRC certification preferred3–5+ years of clinical operations, clinical trial management, or site management experience in a medical device or pharmaceutical environmentSolid understanding of ICH-GCP, FDA IDE regulations, and essential document requirements for investigational device studiesExperience managing regulatory binders, site qualification documentation, and investigational supply logisticsProficiency with clinical trial management systems (CTMS) and electronic trial master file (eTMF) platformsCan-do attitude — highly organized — strong cross-functional communication and stakeholder management skillsWillingness to travel to clinical sites as required; flexibility to support BiVACOR as our program scalesWhat We OfferBiVACOR offers a competitive compensation package and comprehensive benefits, including:401(k) with company matchingMedical, dental, and vision insuranceHealth Savings Account (HSA) & Flexible Spending Account (FSA)Life insurance & Employee Assistance ProgramGenerous paid time offThis 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.