Data Manager

The NIHR UCLH Clinical Research Facility UCLH is a well-established Clinical Research Facility (CRF) covering two sites. The Leonard Wolfson Experimental Neurology Centre is a dedicated neuroscience experimental medicine facility at the National Hospital for Neurology and Neurosurgery (NHNN) at Queen Square (QS); and the NIHR UCLH Clinical Research Facility is a comprehensive Cancer and Medical research facility on the Bloomsbury campus (BC) at Tottenham Court Road.

We are looking to recruit a self-motivated and enthusiastic Data Manager to work in the CRF and be specifically responsible for the management of a portfolio of clinical trials in the CRF. The job role will be working across all therapeutic areas from first-into-human through to complex and innovative phase 3 trials, and experimental non-IMP studies.

The post holder will be expected to ensure high quality data in line with the study protocol, the principles of Good Clinical Practice (GCP) and the UK Medicines for Human Use (Clinical Trials) Regulations.

The post holder will be based at UCLH CRF across two CRF sites as required and based on needs.

• Collect and enter data into electronic or paper Case Report Forms (CRF) from source data files and medical records, following trial specific instructions for data entry.
• Liaise with Clinical Research Associates (CRAs) to ensure all outstanding issues and queries are resolved in a timely and efficient manner, with particular attention to data locks.
• Manage the maintenance of the Investigator Site Files (ISF), ensuring all essential documents are filed contemporaneously.
• Lead preparation and facilitation of monitoring visits with external sponsors.
• Work with the research team to prepare and review study documentation in preparation for Audit and Regulatory Inspection.
• Deliver training to new starters.

For further details / informal visits contact: Name: Luke Townley Job title: Senior Data Manager Email address:

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