Associate II, TMF Operations

📋 Description

• Support TMF approvals, QC reviews, and document processes in SOPs and working practices.
• Process, review, classify, and resolve rejected TMF documents across complex studies.
• Manage essential documents in electronic and hard-copy formats with accurate records.
• Prepare TMF Quality Control checklists and coordinate reviews with project teams.
• Conduct TMF quality control to verify regulatory, ICH GCP, sponsor expectations, SOPs, and best
• Work with electronic document repositories and eTMF systems to review, index, process, and maintain

🎯 Requirements

• University degree preferred, Life Sciences or related discipline.
• Up to 1–2 years of relevant TMF/records management or clinical research experience.
• Understanding of clinical research principles and TMF purpose.
• Experience with data collection, indexing, editing, and standardized naming conventions.
• Experience with electronic document repositories or eTMF platforms; willingness to develop further
• Strong written and verbal communication; ability to present information clearly and concisely.

🎁 Benefits

• Opportunity to build TMF operations and clinical research experience within a global CRO.
• Exposure to international studies, sponsor portfolios, and industry best practices.
• Hands-on experience with electronic TMF and document management technologies.
• Collaborate with experienced professionals across clinical research and project teams.
• Supportive environment that values collaboration, creativity, and development.
• Career development within a global organization focused on improving clinical research and patient