Onsite Senior Clinical Study Lead – Multi-Site Research

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

Benefits offered by this job

Annual Bonus

Onsite Medical Clinic

Onsite Lunch

Tuition Reimbursement

Paid Time Off

401(k) Retirement Plan

Job summary

Arthrex, Inc. is seeking a Sr. Clinical Study Manager for onsite work in Naples, FL. You will lead, develop, and manage clinical research studies from inception through reporting, ensuring compliance with ISO standards and FDA MDR guidelines.

The role requires collaboration with data management, regulatory, and clinical teams, mentoring staff, and overseeing monitoring and budget activities to deliver high-quality study outcomes.

Qualifications

• Experience in designing and managing clinical studies.
• Knowledge of regulatory requirements and ethics in clinical research.
• Ability to manage multiple studies and cross-functional teams.

Responsibilities

• Lead planning, execution, and oversight of clinical studies per protocols and regulations.
• Coordinate IRB communication and study materials.
• Ensure data collection aligns with protocols and manage site monitoring.

Skills

Strategic thinking

Cross-functional collaboration

Regulatory knowledge (FDA MDR ISO)

Clinical study processes

Data collection & analytics

Effective communication

Mentoring

Project leadership

Documentation

Education

Clinical Research Certification

Tools

Microsoft Office

Job description

Arthrex, Inc. is seeking a Sr. Clinical Study Manager for onsite work in Naples, FL. You will lead, develop, and manage clinical research studies from inception through reporting, ensuring compliance with ISO standards and FDA MDR guidelines.

The role requires collaboration with data management, regulatory, and clinical teams, mentoring staff, and overseeing monitoring and budget activities to deliver high-quality study outcomes.