Clinical Research Manager

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 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 Role** This 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 Responsibilities** - Manage all US IDE clinical study operations including site activation, enrolment, and monitoring - Lead and develop a team of Clinical Research Specialists/Site Managers and Clinical Research Associates - Ensure US sites maintain GCP compliance, FDA regulations, and protocol adherence - Serve as the primary liaison with US IRBs, site Principal Investigators, and study coordinators - Maintain the Trial Master File per ICH E6(R2) and ISO 14155:2020; prepare for and support inspections and audits - Collaborate 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 materials - Develop a deep understanding of clinical data; interpret and communicate complex results in a clear, concise, and scientifically accurate manner across a wide range of audiences **What You Bring** - Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related field; advanced degree preferred - 5+ years of clinical research experience in a medical device or pharmaceutical environment, with at least 3 years in a management or team leadership role - Extensive experience managing US IDE studies; thorough knowledge of FDA regulations (21 CFR 812), ICH E6(R2) GCP, and ISO 14155:2020 - Demonstrated experience authoring regulatory and clinical documents including protocols, CSRs, CEPs/CERs, and annual progress reports - Strong data interpretation skills with the ability to synthesize complex clinical results and present them clearly to scientific, regulatory, and lay audiences - Prior experience with cardiac or implantable device studies strongly preferred; Class III medical device experience an advantage - Can-do attitude, strategic thinker with strong leadership and cross-functional communication skills - Willingness to travel to US clinical sites and attend key meetings and conferences as required **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 $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.*