Clinical Trials Ops Lead - Medical Device, Multi-Site

BiVACOR; 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

Health Savings Account (HSA)

Generous paid time off

Job summary

BiVACOR in Huntington Beach is seeking a Clinical Operations Manager to lead the operational framework for groundbreaking clinical studies of the Total Artificial Heart. This role ensures compliance and readiness at all sites, requiring meticulous organizational skills and regulatory knowledge.

The ideal candidate possesses a Bachelor’s in Life Sciences, with 3–5+ years in clinical operations. Responsibilities include overseeing logistics, maintaining documentation, and tracking operational milestones. A competitive salary and comprehensive benefits package are offered.

Qualifications

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

Responsibilities

• Oversee operational logistics for clinical study activities.
• Maintain site qualification and regulatory documentation.
• Track site-level operational milestones and flag deviations.

Skills

Clinical operations

Clinical trial management

Cross-functional communication

Regulatory compliance

Stakeholder management

Travel flexibility

Education

Bachelor’s degree in Life Sciences, Health Sciences, or related field

Tools

Clinical trial management systems (CTMS)

Electronic trial master file (eTMF) platforms

Job description

BiVACOR in Huntington Beach is seeking a Clinical Operations Manager to lead the operational framework for groundbreaking clinical studies of the Total Artificial Heart. This role ensures compliance and readiness at all sites, requiring meticulous organizational skills and regulatory knowledge.

The ideal candidate possesses a Bachelor’s in Life Sciences, with 3–5+ years in clinical operations. Responsibilities include overseeing logistics, maintaining documentation, and tracking operational milestones. A competitive salary and comprehensive benefits package are offered.