Clinical Trials Lead, Medical Devices (Heart Failure)

Theraheart; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k)

Paid time off

Job summary

Theraheart in Irvine, CA is seeking a Clinical Operations Manager to lead clinical trial planning, initiation, execution, and closeout in line with GCP, regulatory requirements, and company standards.

You will partner with R&D, regulatory, medical affairs, investigators, vendors, and CROs to manage timelines, enrollment, documentation, and risk mitigation while ensuring study sites meet quality standards. Up to 30% travel may be required.

Qualifications

• Bachelor's degree in Life Sciences, nursing, biomedical engineering, or related field.
• 5+ years of clinical operations experience in medical device, biopharma, or healthcare settings; heart failure / interventional cardiology preferred.
• Experience with regulatory agencies, core labs, and CROs.
• Strong understanding of clinical trial design, regulatory requirements, and GCP.
• Excellent organizational, project management, and communication skills.

Responsibilities

• Oversee all clinical activities, ensure adherence to protocols, and coordinate with R&D, regulatory, medical affairs, etc.
• Develop, maintain and implement clinical SOPs, work instructions, and training materials for studies in compliance with GCP and company standards.
• Lead and coordinate planning, initiation, execution, and completion of clinical trials.
• Oversee subject enrollment and recruitment strategies
• Manage study timelines, milestones, and resource allocation.
• Ensure trials are conducted in compliance with regulatory and ethical standards.
• Execute study materials development, patient screening, physician training, and trial master file management.
• Identify, qualify, and manage study sites, including initiation, activation, monitoring, data collection, and closeout.
• Support regulatory submission documents for trials.
• Identify risks to timelines/budgets and develop mitigation strategies.
• Liaise with investigators, vendors, and CROs to ensure effective communication throughout the trial.
• Travel up to 30% for site visits, meetings, and conferences.

Skills

Project management

Communication

Regulatory knowledge

GCP familiarity

Stakeholder coordination

Education

Bachelor's degree in Life Sciences / nursing / biomedical engineering

Job description

Theraheart in Irvine, CA is seeking a Clinical Operations Manager to lead clinical trial planning, initiation, execution, and closeout in line with GCP, regulatory requirements, and company standards.

You will partner with R&D, regulatory, medical affairs, investigators, vendors, and CROs to manage timelines, enrollment, documentation, and risk mitigation while ensuring study sites meet quality standards. Up to 30% travel may be required.