Clinical Research Manager

Join Us in Revolutionizing Heart CareAt 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 activate, every team member you develop, and every data point you interpret 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 senior, high-impact leadership role at the center of BiVACOR's US clinical program, where your expertise will shape how we conduct, manage, and report on one of the most groundbreaking medical device studies of our time. As a Clinical Research Manager, you will own end-to-end US IDE study operations, leading a team of clinical research professionals, ensuring regulatory compliance across all active sites, and driving the clinical strategy that will help bring the world's first Total Artificial Heart to patients who need it most. You will bring deep clinical trial expertise, strong leadership instincts, and the scientific acumen to translate complex data into compelling, accurate clinical narratives.Key ResponsibilitiesManage all US IDE clinical study operations including site activation, enrollment, and monitoringLead and develop a team of Clinical Research Specialists/Site Managers and Clinical Research AssociatesEnsure US sites maintain GCP compliance, FDA regulations, and protocol adherenceServe as the primary liaison with US IRBs, site Principal Investigators, and study coordinatorsMaintain the Trial Master File per ICH E6(R2) and ISO 14155:2020; prepare for and support inspections and auditsCollaborate on clinical strategy and author key clinical documents including clinical study protocols, clinical study reports, clinical evaluation plans/reports, annual progress reports, risk-benefit analyses, and clinical marketing materialsDevelop a deep understanding of clinical data; interpret and communicate complex results in a clear, concise, and scientifically accurate manner across a wide range of audiencesWhat You BringBachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or a related field; advanced degree preferred5+ years of clinical research experience in a medical device or pharmaceutical environment, with at least 3 years in a management or team leadership roleExtensive experience managing US IDE studies; thorough knowledge of FDA regulations (21 CFR 812), ICH E6(R2) GCP, and ISO 14155:2020Demonstrated experience authoring regulatory and clinical documents including protocols, CSRs, CEPs/CERs, and annual progress reportsStrong data interpretation skills with the ability to synthesize complex clinical results and present them clearly to scientific, regulatory, and lay audiencesPrior experience with cardiac or implantable device studies strongly preferred; Class III medical device experience an advantageCan-do attitude, strategic thinker with strong leadership and cross-functional communication skillsWillingness to travel to US clinical sites and attend key meetings and conferences as requiredWhat We Offer401(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 $110,000 - $150,000. 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.