Clinical Research Manager

About the Company

BiVACOR is developing the world’s most advanced total artificial heart, a technology capable of saving millions of lives around the world. We are a team united by purpose, working on something truly unprecedented.

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
• Collaborate on clinical strategy and author key clinical documents including protocols, CSRs, and clinical evaluation reports
• Interpret and communicate complex clinical data to scientific and regulatory audiences

Requirements

• Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or related field
• 5+ years of clinical research experience in medical device or pharmaceutical environments
• 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
• Willingness to travel to US clinical sites and attend meetings/conferences

Preferred Qualifications

• Advanced degree
• Prior experience with cardiac or implantable device studies
• Class III medical device experience

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