CPRD FTC Clinical Study Development Manager

We are currently looking for an FTC Clinical Study Development Manager to join our Clinical Practice Research Datalink team in the Safety and Surveillance group.

Please note this opportunity is currently only available to those working within the Civil Service. Applications from non-Civil Servants may not be reviewed and may be rejected.

This is a full-time opportunity, on a fixed term contract basis until 20 May 2025 . The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked in the UK and not overseas.

Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.

We are currently implementing a flexible, hybrid way of working, with a minimum of 4 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 8 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly.

Who are we?

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.

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.

Key responsibilities:

• 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.

Who are we looking for?

Our successful candidate will have:

• 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.

· 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.

Use of AI in Job Applications:

Applicants must ensure that anything submitted must be factually accurate and truthful. Plagiarism 'can include presenting the ideas and experience of others, or generated by artificial intelligence, as your own.

If you require any disability related adjustments at any point during the process, please contact as soon as possible.

If you require any disability related adjustments at any point during the process, please contact as soon as possible.

Shortlisting Date: Friday 31 st May 2024

Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome.

If you need assistance applying for this role or have any other questions, please contact

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 .

Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant's details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.

Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here .

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact .

In accordance with the Civil Service Commissioners' Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should firstly contact Mira Mepa, Head of Recruitment and Operations, .

Create and manage profiles for future opportunities.