Clinical Trial Systems Manager

Job description

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.   

We wish to recruit a Clinical Trials Systems Manager who will be an integral member of the team supporting both commercial and quality teams. The main responsibilities for the postholder 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. The postholder will maintain relevant internal databases for the purposes of tracking performance, ensuring high quality and integrity of data captured. 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.  

This post will be offered on an indefinite contract  contract  

This is a full-time  post

Key responsibilities

1. Oversee all KHP-CTO clinical trial databases and related IT systems (e.g. Research Management Systems, MedDRA , pharmacovigilance).  
2. Liaise with end users (trial managers, CRA’s, statisticians) and senior KHP-CTO staff to identify priorities for database / systems development and data collection innovation. 
3. Provide database and data management assistance to Clinical Trials within the partner organisation in set-up, analysis and close out of the study. 
4. To work with the Quality Manager to deliver the compliance activities required when hosting clinical trials and to address any emergent quality issues 
5. To lead on the migration of data from MATTS (MedSciNets Active Trial Tracking System) to EDGE. 
6. To ensure all relevant databases contain accurate up-to-date data to provide robust metrics and reports as requested. 
7. To produce regular reports, analysis and presentations for National, Board, Trust and departmental levels, for use across a range of decision making, reporting and planning tasks. 
8. To ensure internal staff are trained in the use of internal databases and to provide ongoing support to the Quality and Commercial team regarding these databases. 
9. Take responsibility for professional development and maintain continuing awareness of developments in clinical trial legislation.   

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.  

Skills, knowledge, and experience 

The successful candidate will hold a degree in life sciences or have relevant experience and have evidence of personal professional development with particular focus on keeping self-updated in GCP and regulatory issues. Suitable experience within the pharmaceutical industry and NHS/Academic environments and experience of mentoring or facilitating others is required. The successful applicants will also be an enthusiastic team player.  

The post will be based at Guy’s Campus; however, it is a requirement of employment that the post holder be prepared to work at any additional or different locations owned or served by the College either on an on-going or temporary basis after due consultation. The post holder will be expected to work across all the sites of the partner institutions and external sites participating in Partner Organisation sponsored trials Occasional national and international travel may be required, including overnight. 

Essential criteria  

1.       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   

2.       Knowledge of clinical trial processes, regulatory requirements for clinical trials and GCP 

3.       Experience of database design/management, and the handling of sensitive data 

4.      Experience of clinical trial system implementation in a clinical research environment 

5.       Experience of writing SQL, SQL Server and using clinical data management systems (e.g.: MACRO, CASTOR, REDCap, EDGE) 

6.      Familiarity with legal aspects of information governance (e.g., the Data Protection Act, Freedom of Information Act, Human Tissue Act) 

7.       Experience of clinical trial set up, running and close-out 

8.      Excellent written and verbal communications skills 

9.      Ability to understand, manipulate, analyse and present numerical data in a variety of formats. 

10.   Evidence of personal professional development with particular focus on keeping self-updated in GCP and regulatory issues 

Desirable criteria

11.    Knowledge of medical, scientific and /or research terminology 

12.    Experience in writing and following SOPs 

13.    Experience of web application development 

14.   Experience in managing large datasets 

Further information

The Kings Health Partners Clinical Trials Office (KHP-CTO) is a joint initiative between the member institutions of King’s Health Partners. It has been set up to provide a single interface for those wishing to conduct clinical trials within the Partner Organisations, and to ensure that there are common, efficient processes for the set up and administration of clinical trials. http://www.khpcto.co.uk