Senior Clinical Trial Director – Medical Devices

Regulatory Jobs; Andover (MA); On-site; USD 152,000 - 216,000; Full time

Benefits offered by this job

Medical with HRA

Dental

Vision

Healthcare FSA

Dependent Care FSA

Short Term Disability

Long Term Disability

401K Plan

Pet insurance

Employee Stock Purchase Plan

Job summary

TransMedics, Inc. is seeking a Principal Clinical Trial Manager to lead the development of clinical trial activities and ensure timely, high-quality execution with thoughtful task delegation. The role interfaces with FDA processes and cross-functional teams to drive study success.

The candidate will oversee site interactions, regulatory submissions, and documentation while managing timelines, budgets, and data analyses to support device trials across multiple programs.

Qualifications

• BA/BS in Science, Life Sciences or relevant field.
• 8–10 years’ pharmaceutical drug development, biotech or CRO experience monitoring and managing clinical trials (cardiovascular indications preferred).
• Proven expertise in executing IRB/EC submissions and approvals.

Responsibilities

• Lead pre- and post-market FDA clinical trials with effective organizational strategies and rigorous procedures.
• Create study-specific templates across programs.
• Manage planning, implementation, and tracking of the clinical monitoring process with CRAs.

Skills

Leadership

Communication

Problem solving

Detail oriented

Budget management

Education

BA/BS in Science, Life Sciences or relevant field

Masters in Science, Life Sciences or relevant field

Tools

EDC systems

Job description

TransMedics, Inc. is seeking a Principal Clinical Trial Manager to lead the development of clinical trial activities and ensure timely, high-quality execution with thoughtful task delegation. The role interfaces with FDA processes and cross-functional teams to drive study success.

The candidate will oversee site interactions, regulatory submissions, and documentation while managing timelines, budgets, and data analyses to support device trials across multiple programs.