Clinical Operations Manager

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 is a dynamic, fast-paced startup located in Irvine, CA. We are looking to revolutionize the treatment of heart failure with our innovative ablation catheter technology. The team uses a comprehensive approach to medical device development by considering the needs of patients and medical professionals to ensure the right solutions are brought to the operating room.

Summary:

The Clinical Operations Manager is responsible for leading clinical trial planning, execution, and closeout in compliance with GCP, regulatory requirements, and company standards. This role partners with cross-functional teams, investigators, vendors, and CROs to manage timelines, site operations, enrollment, documentation, and risk mitigation.

Responsibilities

• Oversee all clinical activities, ensures adherence to protocols, and coordinates with R&D, regulatory, medical affairs, etc.
• Develop, maintain and implement clinical SOPs, work instructions, and training materials to ensure medical device clinical studies are conducted consistently and in compliance with GCP, applicable regulations, protocols, and company quality standards.
• Lead and coordinate the planning, initiation, execution, and completion of clinical trials.
• Oversee subject enrollment and recruitment strategies
• Manages study timelines, milestones, and resource allocation.
• Ensure that all clinical trials are conducted in compliance with regulatory guidelines, ethical standards, and company policies.
• Execute clinical trial activities such as study material development, patient screening, physician training, proctoring, follow-up support and trial master file management.
• Identify, qualify, and manage clinical trial sites, including site initiation, activation, monitoring visits, data collection oversight, and study closeout.
• Support regulatory submission documents for clinical trials, including study protocols, informed consent forms, and clinical study reports.
• Identify potential risks to clinical trial timelines, budgets, or outcomes and develop strategies for mitigation. Proactively and creatively address challenges and barriers in the clinical trial process.
• Liaise with investigators, vendors, and clinical research organizations (CROs) to ensure effective communication and collaboration throughout the trial process.
• This position involves up to 30% travel, which may include domestic and international travel for site visits, meetings with external stakeholders, and conferences.

Required Skills & Qualifications

• A bachelor’s degree in Life Sciences, nursing, biomedical engineering, or a related field is required.
• 5+ years of experience in clinical operations within medical device, biopharmaceutical or healthcare settings. Experience in heart failure, interventional cardiology or with class III devices preferred.
• Prior experience working with regulatory agencies, core labs, and contract research organizations (CROs).
• Strong understanding of clinical trial design, regulatory requirements, and GCP (Good Clinical Practice) guidelines.
• Excellent organizational, project management, and communication skills, both written and verbal.

Why Join Theraheart?

This is a unique opportunity to be at the forefront of medical innovation. Your work will help create a new standard of care for patients with heart failure.

• Work in a highly collaborative, innovative, and flexible start-up environment.
• Receive a competitive compensation package commensurate with experience, including market-based compensation and comprehensive benefits (health, dental, vision, 401(k), and paid time off).

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.