Orthopaedic Clinical Research Lead

Medartis; Miami (FL); On-site; USD 110,000 - 160,000; Full time

Job summary

Medartis in Miami seeks a Clinical Research Lead to drive portfolio development of clinical studies, align with regulatory requirements, and coordinate with CROs and sites. The role involves protocol development, data analysis, and scientific writing, with travel up to 20%. A STEM degree (PhD desirable) and experience in orthopedic devices are preferred.

Must relocate to Miami by January 2028. The position focuses on quality systems, study management, and collaboration with internal and external

Qualifications

• Degree in STEM; PhD and GCP desirable.
• Familiar with logistical and regulatory issues in clinical studies.
• Familiarity with orthopedic surgery or orthopedic medical device design preferred.
• Knowledge of statistics is advantageous.
• Fluent English; other languages advantageous.
• Willingness to travel up to 20%.
• Proficient in office applications.
• Willingness to take initiative and act autonomously.

Responsibilities

• Cultivate a portfolio of clinical research projects and sites to support Medartis regulatory and business needs.
• Create and maintain customer contacts for visits, trainings, and advice.
• Develop and maintain processes within the Medartis quality system to meet regulatory requirements.
• Select and support preclinical and clinical studies including registries and PMA-related activities.
• Coordinate with CROs and ensure communication from study conception to publication.
• Oversee regulatory submissions (IRB, ethics commissions, ICH-GCP, ISO 14155).
• Lead protocol development and ensure compliance with FDA indications for use.
• Implement digital tools (EDC, registries, eCRFs) and train staff.

Skills

Clinical research coordination

Regulatory understanding

Data analysis

Scientific writing

Study coordination

Travel readiness

Education

STEM degree (university level)

PhD desirable

GCP certificate desirable

Tools

EDC software

Quality management systems

Job description

Medartis in Miami seeks a Clinical Research Lead to drive portfolio development of clinical studies, align with regulatory requirements, and coordinate with CROs and sites. The role involves protocol development, data analysis, and scientific writing, with travel up to 20%. A STEM degree (PhD desirable) and experience in orthopedic devices are preferred.

Must relocate to Miami by January 2028. The position focuses on quality systems, study management, and collaboration with internal and external