Clinical Trial Manager

Location: Needham, MA (Greater Boston Area)

Work Arrangement: On-site, 5 days per week

About Pi-Cardia

Pi-Cardia is a growth-stage medical device company focused on developing innovative solutions for structural heart disease. Founded in Israel, with expanding operations in the United States, Pi-Cardia combines clinical excellence, technological innovation, and entrepreneurial agility. Our team works closely with leading physicians and global partners to bring meaningful, life-improving therapies to patients worldwide. We are building a high-performance organization that balances rapid growth with operational discipline, regulatory excellence, and a strong people-first culture.

Position Overview

We are seeking an experienced, hands-on Clinical Trial Manager (CTM) to lead the day-to-day execution of U.S. clinical activities for our structural heart technologies.

The CTM will serve as a key U.S.-based Clinical Operations representative, with significant field presence and frequent travel to clinical sites. The role requires strong relationships with investigators and research teams, independent management of study activities, and close collaboration with Pi-Cardia’s Clinical, Regulatory, R&D, Quality, and Field teams.

Key Responsibilities

• Lead execution of U.S. IDE and post-market clinical studies.
• Frequently visit clinical sites and maintain direct relationships with investigators and research coordinators.
• Drive site activation, enrollment, monitoring, follow-up, data quality, and study milestones.
• Identify and resolve site, study, and operational issues proactively.
• Oversee CROs, CRAs, core labs, and other clinical vendors as applicable.
• Support collection and follow-up of clinical safety events, protocol deviations, and product complaints.
• Support investigator meetings, physician interactions, and clinical training activities.
• Ensure compliance with study protocols, GCP, ISO 14155, FDA requirements, and company procedures.
• Provide clear and timely communication to Clinical and Regulatory leadership and collaborate closely with the U.S. field team.

• Bachelor’s degree in life sciences, nursing, biomedical engineering, or related field.
• 5+ years of medical device clinical research experience, preferably including CTM or senior CRA responsibilities.
• Experience with U.S. IDE studies strongly preferred.
• Structural heart, interventional cardiology, or cardiovascular device experience highly preferred.
• Strong site management and physician-facing skills.
• Highly independent, hands-on, organized, and comfortable working in a fast-paced environment.
• Willingness and ability to travel frequently within the U.S.

Annual base salary range: $140,000–$160,000, depending on experience and qualifications.

Equal Opportunity Statement

Pi-Cardia is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.