TMF Classifier I - Remote

Overview

The TMF Classifier I is responsible for managing document classification within clinical studies, ensuring compliance with regulatory requirements and maintaining the Trial Master File (TMF) in an audit-ready state.

In Short

• Manage document classification and deletion under Smart Inbox and ARC review.
• Maintain TMF for clinical studies in accordance with TMF processes.
• Perform visual quality checks on e-documents for clarity and readability.
• Conduct audit readiness checks on documents uploaded in the eTMF system.
• Ensure compliance with company SOPs, sponsor SOPs, GCP, and ICH guidelines.
• Identify operational issues and implement resolutions.
• Prepare TMF for QA or Sponsor audits and implement corrective actions.
• Participate in internal and client audits.
• Collaborate with study team members to ensure client satisfaction.
• Engage in business improvement initiatives to enhance quality and productivity.

Requirements

• Bachelor’s Degree with a focus in Life Sciences or Business.
• 6 to 12 months of experience in a clinical research environment.
• Clear understanding of GCP and ICH guidelines.
• Knowledge of regulatory and clinical document requirements.
• Proficiency in Microsoft Office and Adobe Acrobat.
• Excellent interpersonal skills.
• Master’s Degree preferred; equivalent experience may substitute education.
• Experience with clinical electronic systems is a plus.

Benefits

• Opportunity to contribute to life-saving therapies.
• Engaging work environment focused on teamwork and excellence.
• Career development opportunities within a global talent network.
• Minimal travel requirements.