Job Description

The role

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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?

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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

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You have the essential attributes needed for the role, which include:


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.

Also highly desirable: experience in patent filing and liaising with Technology Transfer Office and Experience with MHRA protocols and requirements for advancing studies/trials along the translational pathway.

Additional information

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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

S

hift

pattern

: 35 hours per week

This advert will close

at

23:59 UK time

on 23/11/2025

For informal queries please contact: Massimo Caputo, Professor of Congenital Heart Surgery - m.caputo@bristol.ac.uk

Our strategy and mission

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We recently launched our strategy to 2030 tying together our mission, vision and values.

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.


JOB NUMBER

SUPP112901

CONTRACT TYPE/WORK PATTERN

Open ended / Full time

POSTING END DATE

23 Nov 2025

FACULTY/DIVISION

Faculty of Health and Life Sciences

SALARY

43,482 - 50,253 per annum