Clinical Operations 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

• 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

Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field
• 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
• Willingness to travel to clinical sites as required

Preferred Qualifications

• Advanced degree or CRA/CRC certification

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