University of Bristol - School of Physiology, Pharmacology and Neuroscience
Trial and Data Manager
University of Bristol - School of Physiology, Pharmacology and Neuroscience, Bristol, Connecticut, us, 06010
The role
The Trial/Data Manager (TM/DM) will lead on all aspects of trial/data management, through all stages, supporting our translational research strategy; acting as the key point of contact with stakeholders to oversee trial conduct, from set‑up to close‑down, including the embedded qualitative process and economic evaluations. The TM/DM will manage multiple studies/trials and ensure these are delivered within the proposed timeframe and in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, applicable legislation.
Hybrid working is available with pattern to be agreed on appointment.
What will you be doing? The postholder is responsible for fostering effective collaboration among all stakeholders, maintaining close communication with sponsors, and coordinating activities delegated to the project team. These include the preparation of annual safety reports for submission to the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA), as well as liaison with the trial statistician to produce regular analytical and progress reports. The role involves engagement with the Technology Transfer Office and the Translational Hub, where appropriate, and the coordination of case report form development, including the production, testing, and validation of electronic case report forms and study databases to ensure the rigorous collection of data required to address the research objectives. Where relevant, the postholder gathers information to support patent filing and intellectual property management.
The postholder ensures the efficient day‑to‑day management, closure, archiving, and dissemination of the trial in strict adherence to the study protocol, standard operating procedures, and regulatory requirements. This includes monitoring for procedural errors and issues related to participant recruitment and retention, and escalating or resolving such matters as appropriate. The role encompasses the development and maintenance of training materials for trial procedures and documentation, ensuring compliance with all ethical, legal, data protection and governance standards, and providing training to relevant staff and collaborators.
The postholder coordinates start‑up and close‑out task groups, prepares agendas, arranges and chairs meetings where applicable, ensures the accurate recording of minutes, and drives forward agreed actions, escalating issues that may affect trial delivery. Oversight of data collection is a key responsibility, ensuring that data are gathered within agreed deadlines, quality‑checked, and verified. Database amendments are implemented where necessary to maintain data integrity and improve accuracy. The postholder monitors progress against milestones, including financial expenditure, authorises payments to external organisations, and produces regular performance and financial reports for internal and external stakeholders, which may include confidential or sensitive information.
Additional responsibilities include the preparation of applications for initial approvals and amendments to regulatory bodies, completion of risk and data protection impact assessments, and maintenance of the Trial Master File and Trial Site Files. The postholder also contributes to the development of academic and impact outputs arising from the trial, supporting the effective dissemination and translation of research findings.
You should apply if
Considerable experience in trial management of multicentre trials and/or other large/complex clinical research studies from start‑up to closure.
A good understanding of the principles of trial design, to include comprehension of relevant terminology and how to implement this knowledge in a practical setting.
A good understanding of REDCap databases and data linkage.
Excellent understanding of the regulatory and governance research environment in the UK (including the devolved nations).
Evidence of the ability to develop, implement and monitor standard operating procedures.
Experience in developing, implementing, and promoting the principles of good data management and working with databases for research activity.
Experience in patent filing and liaising with Technology Transfer Office.
Experience with MHRA protocols and requirements for advancing studies/trials along the translational pathway.
Additional information Contract type:
Open-ended with funding until 01/06/2027
Work pattern:
Full time/1 FTE
Grade:
J
Salary:
£43,482 – £50,253 per annum
School/Unit:
Bristol Medical School
Shift pattern:
35 hours per week
Closing time:
23:59 UK time on 23/11/2025
Contact:
Massimo Caputo, Professor of Congenital Heart Surgery – m.caputo@bristol.ac.uk
The University of Bristol aims to be a place where everyone feels able to be themselves and do their best in an inclusive working environment where all colleagues can thrive and reach their full potential. We want to attract, develop, and retain individuals with different experiences, backgrounds and perspectives – particularly people of colour, LGBT+ and disabled people – because diversity of people and ideas remains integral to our excellence as a global civic institution.
Available documents
Faculty of Health and Life Sciences - October 2024.pdf
Bristol Medical School - October 2023.pdf
SUPP112901 - Trial and Data Manager JD.pdf
#J-18808-Ljbffr
Hybrid working is available with pattern to be agreed on appointment.
What will you be doing? The postholder is responsible for fostering effective collaboration among all stakeholders, maintaining close communication with sponsors, and coordinating activities delegated to the project team. These include the preparation of annual safety reports for submission to the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA), as well as liaison with the trial statistician to produce regular analytical and progress reports. The role involves engagement with the Technology Transfer Office and the Translational Hub, where appropriate, and the coordination of case report form development, including the production, testing, and validation of electronic case report forms and study databases to ensure the rigorous collection of data required to address the research objectives. Where relevant, the postholder gathers information to support patent filing and intellectual property management.
The postholder ensures the efficient day‑to‑day management, closure, archiving, and dissemination of the trial in strict adherence to the study protocol, standard operating procedures, and regulatory requirements. This includes monitoring for procedural errors and issues related to participant recruitment and retention, and escalating or resolving such matters as appropriate. The role encompasses the development and maintenance of training materials for trial procedures and documentation, ensuring compliance with all ethical, legal, data protection and governance standards, and providing training to relevant staff and collaborators.
The postholder coordinates start‑up and close‑out task groups, prepares agendas, arranges and chairs meetings where applicable, ensures the accurate recording of minutes, and drives forward agreed actions, escalating issues that may affect trial delivery. Oversight of data collection is a key responsibility, ensuring that data are gathered within agreed deadlines, quality‑checked, and verified. Database amendments are implemented where necessary to maintain data integrity and improve accuracy. The postholder monitors progress against milestones, including financial expenditure, authorises payments to external organisations, and produces regular performance and financial reports for internal and external stakeholders, which may include confidential or sensitive information.
Additional responsibilities include the preparation of applications for initial approvals and amendments to regulatory bodies, completion of risk and data protection impact assessments, and maintenance of the Trial Master File and Trial Site Files. The postholder also contributes to the development of academic and impact outputs arising from the trial, supporting the effective dissemination and translation of research findings.
You should apply if
Considerable experience in trial management of multicentre trials and/or other large/complex clinical research studies from start‑up to closure.
A good understanding of the principles of trial design, to include comprehension of relevant terminology and how to implement this knowledge in a practical setting.
A good understanding of REDCap databases and data linkage.
Excellent understanding of the regulatory and governance research environment in the UK (including the devolved nations).
Evidence of the ability to develop, implement and monitor standard operating procedures.
Experience in developing, implementing, and promoting the principles of good data management and working with databases for research activity.
Experience in patent filing and liaising with Technology Transfer Office.
Experience with MHRA protocols and requirements for advancing studies/trials along the translational pathway.
Additional information Contract type:
Open-ended with funding until 01/06/2027
Work pattern:
Full time/1 FTE
Grade:
J
Salary:
£43,482 – £50,253 per annum
School/Unit:
Bristol Medical School
Shift pattern:
35 hours per week
Closing time:
23:59 UK time on 23/11/2025
Contact:
Massimo Caputo, Professor of Congenital Heart Surgery – m.caputo@bristol.ac.uk
The University of Bristol aims to be a place where everyone feels able to be themselves and do their best in an inclusive working environment where all colleagues can thrive and reach their full potential. We want to attract, develop, and retain individuals with different experiences, backgrounds and perspectives – particularly people of colour, LGBT+ and disabled people – because diversity of people and ideas remains integral to our excellence as a global civic institution.
Available documents
Faculty of Health and Life Sciences - October 2024.pdf
Bristol Medical School - October 2023.pdf
SUPP112901 - Trial and Data Manager JD.pdf
#J-18808-Ljbffr