Senior Multicenter Clinical Study Lead

Arthrex; Naples (FL); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental & Vision

Life Insurance

401(k) plan

Annual Bonus

Tuition Reimbursement

Onsite clinic

Job summary

Arthrex, Inc. is a global medical device company seeking a Sr. Clinical Study Manager in Naples, FL.

You will lead multicenter clinical studies, ensuring compliance with ethics, ISO standards, and internal procedures, while driving study strategy, site management, monitoring, and budgets. This role requires cross-functional collaboration and mentorship of research staff. The position focuses on delivering high-quality clinical research projects, managing amendments, risk, and site engagement,

Qualifications

• Strong strategic thinking to translate goals into actionable plans.
• Understanding of cross-functional clinical study processes is required.
• Excellent communication, documentation, and data collection skills.
• Ability to define research hypotheses and outcome measures.
• Ability to read surgical techniques and understand instruments.

Responsibilities

• Lead, plan, execute, manage, and oversee multicenter clinical studies per ethics, ISO, and regulations.
• Implement clinical protocols, informed consent forms, and study materials.
• Manage IRB communications and submissions for Arthrex initiatives.
• Coordinate with Data Management to ensure EDC captures required data.
• Train internal staff and lead project teams across studies.
• Make key decisions on amendments and study strategies.
• Monitor sites to ensure conduct meets quality standards.
• Prepare budgets and deliverables for interim and final reports.
• Collaborate with leadership, medical writing, and product management.

Skills

Strategic thinking

Cross-functional processes

Communication

Data collection

Regulatory knowledge

Medical terminology

FDA MDR knowledge

Education

Clinical Research Certification

Job description

Arthrex, Inc. is a global medical device company seeking a Sr. Clinical Study Manager in Naples, FL.

You will lead multicenter clinical studies, ensuring compliance with ethics, ISO standards, and internal procedures, while driving study strategy, site management, monitoring, and budgets. This role requires cross-functional collaboration and mentorship of research staff. The position focuses on delivering high-quality clinical research projects, managing amendments, risk, and site engagement,