First-in-Human Clinical Operations Lead

BiVACOR Inc; Huntington Beach (CA); On-site; USD 118,000 - 154,000; Full time

Benefits offered by this job

401(k) with company matching

Medical, dental, and vision insurance

Generous paid time off

Job summary

BiVACOR Inc in Huntington Beach is looking for a Clinical Operations Manager to lead logistics for clinical studies. You'll ensure compliance and operational readiness for the world’s first Total Artificial Heart clinical trials.

The ideal candidate will have 3-5 years of clinical operations experience, a Bachelor’s degree in Life Sciences, and a solid understanding of GCP and FDA regulations. A competitive salary and benefits package is offered.

Qualifications

• 3–5+ years of clinical operations or clinical trial management experience.
• Solid understanding of ICH-GCP and FDA IDE regulations.
• Experience managing regulatory binders and investigational logistics.

Responsibilities

• Oversee operational logistics for clinical study activities at sites.
• Maintain site qualification documentation and operational SOPs.
• Coordinate supply chain activities related to clinical devices.

Skills

Clinical operations experience

Clinical trial management

Regulatory compliance

Stakeholder management

Attention to detail

Education

Bachelor’s degree in Life Sciences or related field

Advanced degree or CRA/CRC certification

Tools

Clinical trial management systems (CTMS)

Electronic trial master file (eTMF) platforms

Job description

BiVACOR Inc in Huntington Beach is looking for a Clinical Operations Manager to lead logistics for clinical studies. You'll ensure compliance and operational readiness for the world’s first Total Artificial Heart clinical trials.

The ideal candidate will have 3-5 years of clinical operations experience, a Bachelor’s degree in Life Sciences, and a solid understanding of GCP and FDA regulations. A competitive salary and benefits package is offered.