An opportunity has arisen for a Clinical Trial Associate to assist in the management of Clinical Trial Master Files and to provide administrative assistance to the Clinical, Regulatory and PVG Teams.
Key responsibilities:
- Manage Trial Master File (TMF) activities, including set-up, document filing, quality control checks, and archiving of physical files
- Support invoice management by logging invoices, maintaining budget trackers, and preparing site payments in line with study contracts
- Prepare and maintain meeting minutes and study documentation files
- Coordinate clinical trial insurance processes, including annual updates and reporting new studies
- Assist with study site set-up, including preparation and QC of site documentation, Investigator Site Files (ISFs), and other study materials
- Coordinate packaging and shipment of site documentation and equipment for site initiation visits
- Maintain and update study trackers (e.g., contact lists, document tracking, file note logs)
- Provide support for study visits (e.g., Site Initiation Visits and close-outs) as required
- Contribute to data management activities, including data entry, quality control of data listings, and user acceptance testing (UAT) support
What you’ll need to succeed:
- The successful candidate will need to be a very organised team player with meticulous attention to detail, familiar with working in a highly regulated environment and share our high ethical standards and quality focused approach.
- They will also need to be accomplished in using various types of computer systems.
- It would be advantageous to have a formal life-science qualification and or experience of working in the pharmaceutical industry or in healthcare, and or knowledge of ICH GCP.