Clinical Trials Systems Manager

About us

The King’s Health Partners Clinical Trials Office (KHP-CTO) is a collaboration between King’s College London, Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust. It is set up to provide a single interface for those wishing to conduct clinical trials within the partner institutions, and to ensure that there are common, efficient processes for the set up and administration of clinical trials.

About the role

The main responsibilities for the Clinical Trials Systems Manager are to assess the suitability and compliance of computer systems for use in the delivery of drug studies Sponsored or Co-Sponsored by the Partner Organisations;  maintain relevant internal databases for the purposes of tracking performance; ensuring high quality and integrity of data captured; proactively contributing to process improvement, designing and creating internal tools to support workload management and tracking and supporting the development of a KHP dashboard.

The postholder will lead on the collation, analysis and presentation of KHP-CTO performance to internal and external stakeholders. The post holder will also be responsible for training and provision of ongoing support to internal staff on the use of relevant databases and will directly line manage a Data Facilitator.

This is a full-time post (35 Hours per week), and you will be offered an indefinite contract.

About you

To be successful in this role, we are looking for candidates to have the following skills and experience:

Essential criteria

• First degree in a scientific or computational field with practical knowledge of IT systems management and database design within a Clinical Trial setting or significant experience in field of clinical trials in the NHS/Academic and/or commercial sector
• Knowledge of clinical trial processes, regulatory requirements for clinical trials and GCP and experience of clinical trial set up, running and close-out
• Experience of database design/management, and the handling of sensitive data
• Experience of clinical trial system implementation in a clinical research environment
• Experience of writing SQL, SQL Server and using clinical data management systems (e.g.: MACRO, CASTOR, REDCap, EDGE)
• Familiarity with legal aspects of information governance (e.g., the Data Protection Act, Freedom of Information Act, Human Tissue Act)
• Excellent written and verbal communications skills and the ability to understand, manipulate, analyse and present numerical data in a variety of formats
• Evidence of personal professional development with particular focus on keeping self-updated in GCP and regulatory issues

Desirable criteria

• Knowledge of medical, scientific and /or research terminology
• Experience in writing and following SOPs
• Experience of web application development
• Experience in managing large datasets

Downloading a copy of our Job Description

Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the next page after you click the “Apply” button, above. This document will provide information of what criteria will be assessed at each stage of the recruitment process.

Further Information

We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.

We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King's.

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