Clinical Trial Manager

Clinical Trial Manager

USA (Remote, Travel Required)

$140,000 - $175,000

Job Description

EPM Scientific is partnered with an innovative structural heart medical device company developing next-generation technologies to improve outcomes for patients with valvular heart disease. The organization is seeking a hands-on Clinical Trial Manager to lead the execution of U.S. clinical studies and serve as a key member of the Clinical Operations team. This individual will work closely with investigators, clinical sites, CROs, and internal stakeholders to drive successful study execution from site activation through study closeout. This is an excellent opportunity for a clinical professional who enjoys field-based engagement, cross-functional collaboration, and making a direct impact on the development of novel cardiovascular therapies.

Key Qualifications

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, or a related field.
• 5+ years of medical device clinical research experience, including Clinical Trial Manager, Senior CRA, or equivalent responsibilities.
• Experience managing U.S. IDE clinical trials preferred.
• Strong knowledge of GCP, ISO 14155, FDA regulations, and clinical trial best practices.
• Prior experience in structural heart, cardiovascular, or interventional cardiology devices strongly preferred.
• Demonstrated ability to manage investigator relationships, clinical sites, and external vendors.
• Strong organizational, problem-solving, and communication skills.
• Willingness to travel extensively throughout the United States.

Roles & Responsibilities

• Lead day-to-day execution of U.S. IDE and post-market clinical studies.
• Build and maintain strong relationships with investigators, research coordinators, and clinical site personnel.
• Drive site activation, enrollment, monitoring activities, patient follow-up, and study milestones.
• Identify and resolve clinical, operational, and site-related challenges proactively.
• Oversee CROs, CRAs, core laboratories, and other clinical vendors.
• Support management of adverse events, protocol deviations, product complaints, and clinical safety reporting.
• Assist with investigator meetings, physician training programs, and clinical education initiatives.
• Ensure compliance with study protocols, FDA regulations, GCP, ISO 14155, and internal quality requirements.
• Collaborate closely with Clinical, Regulatory, Quality, R&D, and Field teams while providing regular study updates to leadership.

Benefits

• Comprehensive medical, dental, and vision coverage
• 401(k) with company contribution
• Competitive PTO and paid holidays
• Opportunity to work alongside leading structural heart physicians and investigators
• Exposure to breakthrough cardiovascular technologies and pivotal clinical programs
• Career growth within a fast-growing medical device organization
• Highly visible role with direct impact on clinical and business success