Trial and Data Manager

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? (key elements and duties the post-holder will carry out):

The postholder will:

• Serve as primary contact for the trial, ensuring effective collaboration with all stakeholders and maintaining close communication with sponsors.
• Coordinate delegated activities such as annual safety reports for MHRA/HRA and statistical reporting with the trial statistician.
• Engage with the Technology Transfer Office/Translational Hub when relevant and oversees the development, testing, and validation of case report forms and electronic study databases.
• Collect information to support potential patent filings and intellectual property processes.
• Manage day-to-day trial operations, including closure, archiving, and dissemination, ensuring compliance with protocols, SOPs, and regulatory standards.
• Monitor errors, recruitment or retention issues, and escalates or resolves problems as needed.
• Develop and maintain training materials, ensuring all staff follow ethical, legal, and data protection requirements.
• Coordinate trial start-up/close-out groups, prepares agendas, arranges or chairs meetings, records minutes, and advances actions affecting delivery.
• Oversee timely data collection, performs quality checks, implements database updates, and improves data accuracy.
• Track progress against milestones, monitors expenditure, authorises payments, and prepares performance and financial reports for stakeholders.
• Prepare regulatory submissions for approvals/amendments and completes risk and data protection impact assessments.
• Maintain Trial Master File and Trial Site Files and contributes to academic and impact outputs to support dissemination.

You should apply if (what experience is necessary for candidates to possess, to drive self-selection):

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.

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