Applications are invited from individuals with a background in programming of clinical research databases (in particular for CTIMP research) and a solid understanding of Sponsor Good Clinical Practice (GCP) compliance activities. The successful candidate will join the Joint Research Management Office (JRMO), supported by systems/applications experts from Research IT Services (Queen Mary University of London) and the Research Data Warehouse Team (Barts Life Sciences Precision Medicine/Barts Health NHS Trust).
Main duties of the job
This newly established role within the JRMO involves leading the development, review, support and validation, of research databases coupled with the training and conduct of Sponsor oversight services for Queen Mary University of London and Barts Health NHS Trust. The post holder will optimize the use of REDCap and other academic and commercial data management systems, ensuring these resources are compliant with regulatory requirements. They will be a key member of the GCP and Compliance Team, overseeing all aspects of database management and compliance for clinical research projects
- Evidenced knowledge of governance and legislative frameworks for data capture in clinical research, including GCP.
- A degree in a relevant subject.
- Evidenced experience of clinical trials database oversight, in particular MHRA regulated research
- Technical programming skills in database creation.
- Strong communication skills to engage with a wide range of stakeholders.
Person Specification
Qualifications
Essential
- Degree or equivalent level of professional qualification in subject area.
- Additional specialist knowledge/ accreditation gained through training and/or experience.
Desirable
- Current GCP qualification
- Data programming qualification
- Currently working on MHRA regulated studies
Experience
Essential
- Proven experience of working with database systems in a research environment
- Strong understanding of the current regulatory environment
Desirable
- MHRA inspection of clinical trial databases
- Experience with REDCap application
- Experience in writing complex SQL queries and presenting the results of those queries to non-technical users
- Clinical trial database management experience
Knowledge
Essential
- Understanding of the key principles of legislation including Data Protect Act 2018 and the EU General Data Protection Regulation (GDPR).
Desirable
- Knowledge of the MHRA Clinical Trial Regulations and its application to regulatory compliance of research databases
Skills
Essential
- Proficient in database management with proven ability to apply skills to the development, testing and implementation of clinical trial data management procedures.
- Expert in identifying areas for collaborative work and analysing performance relating to clinical trial Previous experience writing MHRA Regulation compliant complex Data Management Plans and Requirement Specification Documents and their detailed appraisal. databases.
- Skilled in the design, maintenance of complex relational databases and clinical data management systems such as eCRFs
- Excellent organisational, written, verbal communication and interpretation skills as well as a strong capacity to troubleshoot
- Proven Administrative and project management skills
Desirable
- Previous experience writing MHRA Regulation compliant complex Data Management Plans and Requirement Specification Documents and their detailed appraisal
Other
Essential
- Proficient in producing standard operating procedures and other guidance documents and oversee their implementation.
- Skilled in overseeing multiple active research projects, Vendor selection for MHRA compliant database systems. ensuring milestones are met and progress is communicated through high quality outputs.
- Excellent numeracy and accuracy skills with a high level of attention to detail
Desirable
- Vendor selection for MHRA compliant database systems.
Skills
Essential
- Effective communicate at all levels, capable of discussing highly complex, sensitive or contentious information orally and in writing
Other
Essential
- Effective team player, capable of supporting others and constructively challenging colleagues’ views and attitudes when necessary
- Strong ability to prioritise work and manage deadlines
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Closing Date: 22 May 2025
