Clinical Trial Manager

PI-Cardia • Boston, MA

17h • Onsite

About The Position

Pi-Cardia is seeking an experienced, hands-on Clinical Trial Manager to lead the day-to-day execution of U.S. clinical activities for its structural heart technologies. The CTM will be a key U.S.-based Clinical Operations representative, with significant field presence and frequent travel to clinical sites. The role involves building relationships with investigators and research teams, independently managing study activities, and collaborating with Clinical, Regulatory, R&D, Quality, and Field teams.

The position is based on-site in Needham, Massachusetts, five days per week. The annual base salary range is $140,000–$160,000, depending on experience and qualifications.

Pi-Cardia is a growth-stage medical device company focused on solutions for structural heart disease. Founded in Israel, the company is expanding its U.S. operations and works with physicians and global partners to develop therapies for patients worldwide. Pi-Cardia states that it is an equal opportunity employer committed to diversity and an inclusive environment.

Requirements

• Bachelor’s degree in life sciences, nursing, biomedical engineering, or a related field.
• At least 5 years of medical device clinical research experience.
• Strong site management and physician-facing skills.
• Highly independent, hands-on, and organized, with comfort working in a fast-paced environment.
• Willingness and ability to travel frequently within the U.S.

Nice To Haves

• Experience with U.S. IDE studies is strongly preferred.
• Structural heart, interventional cardiology, or cardiovascular device experience is highly preferred.
• CTM or senior CRA responsibilities are preferred.

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.
• Proactively identify and resolve site, study, and operational issues.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior