Clinical Study Lead — Medical Devices

Argon Medical Devices, Inc.; Plano (TX); On-site; USD 110,000 - 160,000; Full time

Job summary

Argon Medical Devices, Inc. is seeking a Clinical Study Manager to lead and oversee clinical investigations across the device lifecycle, ensuring ISO 14155, FDA, and GCP compliance. You will partner with Regulatory, Quality, Medical Affairs, and Product Development to generate robust evidence supporting safety and performance.

The role requires hands-on study management, site initiation, budgeting, vendor oversight, and data integrity, with travel to sites as needed.

Qualifications

• 3+ years in clinical research.
• 2+ years in medical device study management.
• Experience with pre-market and post-market medical device studies.
• Hands-on site start-up, enrollment management, monitoring, and CRO oversight.
• Familiarity with ISO 14155, FDA, EU MDR, and GCP.

Responsibilities

• Lead design and execution of clinical studies per strategy.
• Oversee budgets, timelines, vendors, and data quality.
• Ensure regulatory compliance across studies and TMF readiness.
• Develop study documentation including protocols and CRFs.
• Coordinate site feasibility, initiation, monitoring, and close-out.

Skills

Clinical research

Project management

Regulatory compliance

Cross-functional teamwork

Education

Bachelor’s degree

Master’s degree preferred

PhD preferred

Tools

EDC

CTMS

eTMF

Job description

Argon Medical Devices, Inc. is seeking a Clinical Study Manager to lead and oversee clinical investigations across the device lifecycle, ensuring ISO 14155, FDA, and GCP compliance. You will partner with Regulatory, Quality, Medical Affairs, and Product Development to generate robust evidence supporting safety and performance.

The role requires hands-on study management, site initiation, budgeting, vendor oversight, and data integrity, with travel to sites as needed.