Job summary Applications are invited from individuals with a background in clinical research databases and a solid understanding of Good Clinical Practice (GCP). 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, validation, training and oversight of clinical trials database management 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 for clinical research projects.Qualifications and Experience:o A degree in a relevant subject.o Prior experience with clinical trials databases.o Comprehensive knowledge of governance and legislative frameworks for data capture in clinical research, including GCP.o Technical skills in database creation.o Strong communication skills to engage with a wide range of stakeholders.Employment Details:o Full-time position.o Based at the Joint Research Management Office, Barts Health, Dept. W, Mile End Road, with a current onsite attendance requirement of twice per week (subject to change). About us Barts Health is one of the largest NHS trusts in the country, and one of Britain's leading healthcare providers. The Barts Health group of NHS hospitals is entering an exciting new era on our improvement journey to becoming an outstanding organisation with a world-class clinical reputation. Having lifted ourselves out of special measures, we now have the impetus and breathing space to chart a fresh course in which we are continually striving to improve all our services for patients. Our vision is to be a high-performing group of NHS hospitals, renowned for excellence and innovation, and providing safe and compassionate care to our patients in east London and beyond. That means being a provider of excellent patient safety, known for delivering consistently high standards of harm-free care and always caring for patients in the right place at the right time. It also means being an outstanding place to work, in which our WeCare values and behaviours are visible to all and guide us in how we work together. We strive to live by our WeCare values and are committed to promoting inclusion, where every staff member has a sense of belonging. We value our differences and fully advocate, cultivate and support an inclusive working environment. Date posted 27 December 2024 Pay scheme Agenda for change Band Band 7 Salary £54,320 to £60,981 a year Per annum inc Contract Fixed term Duration 3 years Working pattern Full-time, Flexible working Reference number 259-6898734GSS Job locations Dept W, 81 Mile End Road London E1 4UJ Job description Job responsibilities We are dedicated to being an outstanding place to work and will work with you to get the best experience. We know flexible working is not a one size fits all and will mean something different to everyone. We are inclusive, so if you are interested in flexible working, please speak to the recruiting manager. The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience, and knowledge required. For both documents, please view the attachment/s below Informal Enquiries: For informal enquiries about this post, please contact Rebecca Newton, Senior GCP and Compliance Manager, at Rebecca.newtonqmul.ac.uk. Job description Job responsibilities We are dedicated to being an outstanding place to work and will work with you to get the best experience. We know flexible working is not a one size fits all and will mean something different to everyone. We are inclusive, so if you are interested in flexible working, please speak to the recruiting manager. The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience, and knowledge required. For both documents, please view the attachment/s below Informal Enquiries: For informal enquiries about this post, please contact Rebecca Newton, Senior GCP and Compliance Manager, at Rebecca.newtonqmul.ac.uk. 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 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. Certificate of Sponsorship 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). Additional information 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. Certificate of Sponsorship 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). Employer details Employer name Barts Health NHS Trust Address Dept W, 81 Mile End Road London E1 4UJ Employer's website https://www.bartshealth.nhs.uk (Opens in a new tab)