Data Manager (Digitally Enabled Trials)

MGPHS / USHER Institute / ECTU

Full time post (35 hours per week) 

The Edinburgh Clinical Trials Unit at the Usher Institute within The University of Edinburgh is looking for a Data Manager to become part of our digitally enabled clinical trials team. This is a new appointment within the unit to lead the support for clinical trials involving personally identifiable linked data from multiple sources. Working within the wider Data Management & Programming Team, you will lead the activity to define requirements for data management and curation within digitally enabled clinical trials, and act as the main point of contact for researchers, stakeholders and Trusted Research Environment (TRE) providers for such trials. With central Information Governance you will define, plan, curate and audit data flows into and out of the ECTU TREs, and maintain oversight of data held within, while liaising with all relevant stakeholders to ensure completion of regulatory documentation. You will have experience in data linkage and in the use of confidential/sensitive patient data, and will be responsible for the construction and operation of trial database systems supporting digitally enabled clinical trials in a strict regulatory environment.

The Opportunity:

This is an exciting opportunity to join the Edinburgh Clinical Trials Unit (ECTU), a leading registered trials unit based within the Usher Institute at Edinburgh Bioquarter. ECTU has a proven track record on delivering research and answering important questions about treatment and service delivery within the NHS. We work closely with patient groups and clinicians who are outstanding in their field. As a valued member of the ECTU Data Management & Programming Team, you will lead essential data management and Information Governance functions pivotal to the successful delivery of a wide and complex trial portfolio.

Informal enquiries may be directed to Kenton D’Mellow, Data Management & Programming Team Lead (Kenton.D’Mellow@ed.ac.uk) Interviews will be held in June. Shortlisted candidates will be asked to prepare a presentation.

Your skills and attributes for success:  

• Experience in data linkage/routinely collected healthcare data/confidential and sensitive data.
• Experienced in a GCP or GMP environment, with the ability to interpret and conform to regulatory requirements for the delivery of clinical trials.
• Experience of Trusted Research Environment (TRE) use and administration.
• The ability to lead and coordinate ECTU’s Information Governance activities, and advise the Unit on regulatory developments.
• Experience of Linux or Unix systems.

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