CPRD FTC Clinical Study Development Manager

The Clinical Study Development Manager is responsible for leading on and contributing to the for the specification, development and configuration of the CPRD online platforms, the CPRD Data Analytics Recruitment Tool (DART) and REDCap, as part of the service delivery.

Responsibilities include: contributing to study planning, liaising with Sponsors and CPRD staff to configure, test and produce study specific modules for the online platforms; producing and overseeing required system and other required documentation; delivering the Electronic Data Capture (EDC) system; contributing to continued development of DART; and managing clinical studies involving the use of the online platforms. You will be familiar with configuring and carrying out user acceptability testing (UAT) of online tools to meet user and service requirements and have experience in clinical research operations.,

• Develop and configure IR web-based platforms


• Deliver Electronic Data Capture (EDC) systems


• Contribute to ongoing improvement of the Interventional Research platforms


• Manage real world clinical studies and people management., We use the Civil Service Success Profiles to assess our candidates, find out more here.



• Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application.



• Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.



• Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.


Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.


• A healthcare or life sciences degree or equivalent work experience.


• Previous experience a clinical operations or clinical research role.


• Previous experience in an Acceptance Testing environment and experience in the development and use of Electronic Data Capture (EDC).


• Experience in drafting system specifications and associated documentation.


• Proficiency in operability of online EDC systems designed to meet user requirements and sound knowledge of clinical trial requirements and procedures., Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here.


Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks.

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

The Safety and Surveillance Group brings together into a single integrated structure devices and medicines safety expertise with enforcement capabilities. These functions will be supported by our data and evidence generating capabilities complementing our signal generating capabilities produced via the new Safety Connect System.

Part of the Safety and Surveillance group, The Clinical Practice Research Datalink (CPRD), with support from the National Institute for Health and Care Research (NIHR), is the UK's preeminent research service providing access to anonymised NHS data for research. In addition to supporting high quality observational research, CPRD has developed world leading services based on using real world data to support clinical trials and interventional studies.

What's the role?

This role offers an exciting opportunity to contribute to the UK Government's premier data-driven research service.