Clinical Trial Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the comprehensive execution of clinical trials, from initiation to completion.

• Oversee daily study operations across various sites, Contract Research Organizations (CROs), and vendors.

• Ensure compliance with protocols and maintain high standards of data collection.

• Work in partnership with Medical Affairs, Quality Assurance, Regulatory Affairs, and Marketing/Market Access teams.

• Monitor study budgets and financial forecasts.

• Provide support to Regulatory Affairs regarding Investigational Device Exemption (IDE) pathways and study requirements.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Nursing, or a related discipline.

• Over 8 years of experience in clinical research, including 1 to 3 years as a Clinical Trial Manager.

• Proven experience in managing clinical trials for medical devices.

• In-depth understanding of ISO 14155 or ICH E6 (R3) FDA clinical trial regulations.

• Experience in collaborating with CROs and vendors.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance.

• 401(k) plan featuring employer contributions and matching options.

• Generous paid time off, including vacation and sick leave.

• Paid time for volunteering activities.

• Annual performance-based bonus incentive program.

• Highly competitive benefits package sponsored by the company.

• Wellbeing programs that foster a culture of excellence.