Clinical Program Manager - REMOTE

Jobgether•Prior Lake, MN

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 have the opportunity to manage and execute global clinical studies that make a difference in the medical field. Collaborating closely with the Clinical Affairs team, you'll ensure that all regulatory requirements are met while advancing innovative medical solutions. Your contributions will directly impact study performance and compliance, driving meaningful change for patients and healthcare providers. We're looking for an experienced professional who is ready to lead in a dynamic and fast-paced environment.

Requirements

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

Responsibilities

Manage clinical trials from inception to Clinical Study Report completion.
Ensure timely and budget-compliant completion of clinical trial activities in a dynamic environment.
Create and implement study-specific clinical monitoring tools and documents.
Lead the identification, evaluation, selection, and oversight of clinical trial sites.
Author and implement operational plans for efficient study enrollment and monitoring activities.
Review and approve vendor and site invoices, tracking study budget closely.
Oversee the Trial Master File for inspection readiness.
Drive cross-functional team support in the development of study documents.
Lead the creation of project plans and reports.
Review and approve site-specific documents and provide study updates.
Conduct internal and external meetings, including Investigator Meetings.
Provide oversight of ongoing study activities.
Support study training for investigators and site staff.
Participate in audits and regulatory inspections as needed.
Perform additional duties as assigned.