Senior Clinical Study Manager — Orthopedics (Global Lead)

Arthrex GmbH; Naples (FL); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Annual Bonus

Wellness Incentive Program

Free Onsite Medical Clinics

Free Onsite Lunch

Tuition Reimbursement Program

Matching 401(k) Retirement Plan

Paid Time Off

Employee Assistance Provider (EAP)

Job summary

Arthrex, Inc. in Naples, FL, a global medical device company focused on orthopedics, seeks a Sr. Clinical Study Manager to lead multicenter studies and drive strategy across study operations.

You will oversee protocol development, site management, monitoring, budgets, and cross-functional collaboration to ensure ethical, regulatory, and ISO compliance. The role offers mentorship, leadership responsibilities, and opportunities to advance portfolio objectives while partnering with medical writing,

Qualifications

• Strong strategic thinking with the ability to translate goals into actionable project plans.
• An understanding of cross-functional clinical study processes is required.
• Ability to work in a team, good communication, documentation, and a strong understanding of data collection and analytical processes are required.
• The ability to identify a research hypothesis and proposed outcome measures to address the hypothesis is required.
• The ability to read a surgical technique and have a basic understanding of the instruments necessary to perform the procedure is required.
• Able to communicate effectively with physicians, key opinion leaders, and other healthcare personnel.
• Must have a strong understanding of federal regulations relating to clinical studies (FDA, MDR), ISO, and research ethics.
• Experience in managing research contracts and protocol development is preferred.
• Experience in post-market, real world evidence, longitudinal or health economics studies is preferred.

Responsibilities

• Lead and oversee multicenter clinical studies from protocol to final report.
• Institute and manage study materials, consent forms, and regulatory submissions.
• Coordinate IRB submissions and communications.
• Train staff and mentor research team members.
• Manage budgets and monitor site performance and data collection.
• Ensure compliance with ISO, FDA/MDR, and ethics requirements.
• Oversee site visits, monitoring reports, and risk management.

Skills

Strategic thinking

Cross-functional processes

Communication

Data collection & analytics

Regulatory knowledge (FDA/MDR, ISO)

Contract management

Protocol review

Mentoring staff

Education

Clinical Research Certification

Tools

Microsoft Office

Job description

Arthrex, Inc. in Naples, FL, a global medical device company focused on orthopedics, seeks a Sr. Clinical Study Manager to lead multicenter studies and drive strategy across study operations.

You will oversee protocol development, site management, monitoring, budgets, and cross-functional collaboration to ensure ethical, regulatory, and ISO compliance. The role offers mentorship, leadership responsibilities, and opportunities to advance portfolio objectives while partnering with medical writing,