Clinical Study Manager - Global Trials & Compliance Lead

Medacta USA, Inc.; Franklin (TN); On-site; USD 110,000 - 160,000; Full time

Job summary

Medacta USA is seeking a Clinical Study Manager to help oversee routine clinical trial activities, ensuring high quality and ethical standards. The role requires independence, strong organizational skills, and extensive experience in clinical research with travel to sites as needed.

Under the Director of Clinical Research, you will manage documents, budgets, reporting, and site training to maintain regulatory compliance and data integrity in a collaborative team environment.

Qualifications

• Bachelor’s Degree in related healthcare discipline; clinical research experience considered.
• Certified Clinical Research Professional preferred; knowledge of IRB policies, ICH GCP guidelines, FDA regulations.

Responsibilities

• Oversee preparation of clinical documents such as protocols, investigator brochure, annual report updates, case report forms and clinical study reports, monitoring plans, and budgets.
• Manage site recruitment, budget and agreement negotiations, study initiation, trial maintenance, data monitoring, data reporting, and study file maintenance.
• Monitor data integrity and use reports/EDC systems to address barriers to project completion.
• Provide training and guidance to site staff regarding compliance with regulatory guidelines and the protocol.
• Assist in SAE reporting and audit-ready documentation.

Skills

Study management

Independent work

Data systems

Confidential handling

Organization

Time management

Travel readiness

Education

Bachelor’s Degree in Healthcare

Tools

EDC systems

Job description

Medacta USA is seeking a Clinical Study Manager to help oversee routine clinical trial activities, ensuring high quality and ethical standards. The role requires independence, strong organizational skills, and extensive experience in clinical research with travel to sites as needed.

Under the Director of Clinical Research, you will manage documents, budgets, reporting, and site training to maintain regulatory compliance and data integrity in a collaborative team environment.