Clinical Program Manager - Remote

Overview

This position involves developing, managing, and executing global clinical studies, ensuring compliance with regulatory requirements and enhancing study performance.

In Short

• Manage clinical trials from inception to completion.
• Ensure timely and budget-compliant trial activities.
• Create and implement study-specific monitoring tools.
• Lead the selection and oversight of clinical trial sites.
• Author operational plans for study enrollment.
• Review vendor and site invoices, tracking study budget.
• Oversee Trial Master File for inspection readiness.
• Support cross-functional teams in developing study documents.
• Conduct ongoing study data reviews and data cleaning activities.
• Develop training for investigators and site staff.

Requirements

• Bachelor's degree in a relevant area of study.
• 2-3 years of clinical trial management experience.
• Minimum of 5 years' experience in the medical device industry.
• Knowledge of FDA and EU regulatory environments.
• Excellent written and verbal communication skills.

Benefits

• Comprehensive benefits package including health, dental, and vision insurance.
• Life, short-term, and long-term disability insurance.
• 401(k) plan.
• Paid time off.
• Equal opportunity employer, valuing diversity and inclusion.