Clinical Program Manager - REMOTE

Jobgether

4d • Remote

About The Position

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Clinical Program Manager. In this role, you will develop, manage, and execute global clinical studies, playing a crucial part in ensuring compliance with regulatory requirements. Your expertise will help enhance study performance and streamline operations. This position allows for significant input into trial design and management, making a meaningful impact on the advancement of medical technology and patient care.

Requirements

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

Nice To Haves

• IDE trial experience preferred

Responsibilities

• Manage clinical trials from inception to completion of Clinical Study Report (CSR)
• Ensure timely and budget-compliant trial activities in accordance with quality standards
• Create and implement study-specific monitoring tools and documentation
• Lead the selection and oversight of clinical trial sites
• Author and implement operational plans for study enrollment and monitoring
• Review vendor and site invoices, tracking study budget in collaboration with finance
• Oversee Trial Master File for inspection readiness
• Support cross-functional teams in developing study documents
• Create project plans, logs, templates, and newsletters
• Review and approve site specific documents such as consent forms and budgets
• Provide study updates and reports detailing risks and issues
• Lead internal and external meetings, including Investigator Meetings
• Conduct ongoing study data reviews and data cleaning activities
• Oversee site initiation, data quality, and close out activities
• Develop training for investigators and site staff
• Participate in internal process audits and regulatory inspections
• Other duties as assigned

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 11-50 employees