Associate Clinical Trial Manager - Remote

Overview

4DMT seeks a motivated and experienced Associate Clinical Trial Manager to support the Company's clinical trial activities. This position will be responsible for supporting the day-to-day operations of one or more phase 1-3 clinical trials including trial start up, conduct and close-out activities.

In Short

• Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Management.
• Collect, track and conduct initial review for completeness of site regulatory documents for IP release and/or TMF filing.
• Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF).
• Maintain multiple tracking spreadsheets following the progress of assigned clinical trials.
• Track and coordinate CRO and third-party vendor activities.
• Receive and review all regulatory documents from sites for accuracy and compliance.
• Ensure timely updates are provided to CTM for updating of ‘Clinicaltrial.gov’.
• Track and route new CDAs, contracts and Work Orders through established legal approval process.
• Perform first pass review of all site and vendor invoices.
• Assist with the development of site tools and clinical trial start-up activities.

Requirements

• BA/BS, degree required.
• At least 5 years of work experience supporting clinical trials.
• Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements.
• Proficient computer skills, specifically with Microsoft Office Suite.
• Ability to prioritize and manage competing priorities.
• Team oriented and ability to effectively collaborate with study team and external partners.

Benefits

• Equal employment opportunities to all employees and applicants.
• Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.