Principal Clinical Trial Manager – Medical Devices (Global)

TransMedics, Inc.; Andover (MA); On-site; USD 152,000 - 216,000; Full time

Job summary

TransMedics, Inc. is seeking a Principal Clinical Trial Manager to lead device-focused clinical programs with a focus on cardiovascular indications. The role drives end-to-end trial execution, startup through close-out, ensuring GCP/ICH compliance and timely, high-quality results.

Responsibilities include IRB/EC submissions, trial material management, budget tracking, and coordination with FDA regulatory and data teams. Travel up to 25% is expected as the program expands.

Qualifications

• BA/BS in Science, Life Sciences or relevant field.
• 8-10 years’ pharmaceutical drug development or biotech experience in clinical trials.
• Experience with IRB/EC submissions and FDA/ICH regulations.

Responsibilities

• Lead pre- and post-market clinical trials for FDA with rigorous procedures.
• Oversee trial start-up, conduct, and close-out activities per standards.
• Monitor timelines, budgets, and data quality; report to management.
• Collaborate with regulatory, data management, and vendors; ensure GCP compliance.

Skills

Leadership

Project management

Regulatory knowledge (FDA/ICH/GCP)

Clinical trial management

Communication skills

Education

BA/BS in Science or Life Sciences

Masters in Science/Life Sciences

Job description

TransMedics, Inc. is seeking a Principal Clinical Trial Manager to lead device-focused clinical programs with a focus on cardiovascular indications. The role drives end-to-end trial execution, startup through close-out, ensuring GCP/ICH compliance and timely, high-quality results.

Responsibilities include IRB/EC submissions, trial material management, budget tracking, and coordination with FDA regulatory and data teams. Travel up to 25% is expected as the program expands.