Associate II, TMF Operations

📋 Description

• Perform TMF Approver and/or TMF QC Reviewer activities per SOPs.
• Process, review, classify, and resolve rejected TMF documents.
• Manage essential documents in electronic and hard-copy formats.
• Prepare TMF QC checklists and coordinate reviews with project teams.
• Ensure regulatory compliance, ICH GCP, and industry best practices.
• Work with electronic document repositories and eTMF systems.

🎯 Requirements

• University degree preferred in Life Sciences or related field.
• 1–2 years in TMF operations, records management, or clinical research.
• Understanding of clinical trial processes and TMF purpose.
• Experience with electronic document repositories or eTMF platforms.
• Strong written and verbal communication, attention to detail.
• Proficiency with MS Word and Excel.

🎁 Benefits

• Gain TMF operations experience in a global CRO.
• Exposure to international studies and sponsor portfolios.
• Hands-on experience with electronic TMF technologies.
• Collaborate with professionals across clinical research teams.
• Supportive environment focused on development and inclusion.
• Meaningful work contributing to trial quality and patient outcomes.