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As a Clinical Trials Associate, you will support the successful delivery of clinical studies through effective coordination, documentation management, and administrative support. A core focus of this role will be ownership and maintenance of the TMF, ensuring compliance with regulatory standards and inspection readiness.
Job Responsibility:
Managing Trial Master File (TMF) activities, including set-up, maintenance, QC checks, and archiving
Ensuring TMF completeness, accuracy, and inspection readiness throughout the study lifecycle
Supporting clinical trial administration across study start-up, conduct, and close-out activities
Preparing and maintaining study documentation, meeting minutes, and tracking logs
Assisting with site set-up activities, including preparation and QC of Investigator Site Files (ISFs)
Coordinating shipment of essential documents and materials to clinical sites
Supporting study visits such as Site Initiation Visits and study close-outs
Assisting with invoice tracking, budget monitoring, and site payments
Contributing to data management activities including data entry and quality control
Requirements:
At least 2 years of recent experience working within clinical trials
Strong hands-on experience managing or supporting Trial Master Files (TMF)
A solid understanding of working in a regulated environment (GCP)
Excellent organisational skills and attention to detail
Confidence using electronic systems and managing documentation
Strong communication skills and the ability to work collaboratively across teams