CPRD FTC Clinical Study Development Manager - £42,869 p.a. + benefits

at  Medicines and Healthcare products Regulatory Agency

JOB SUMMARY

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.
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.
We are currently operate a flexible, hybrid way of working, with a minimum of 8 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 12 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.

JOB DESCRIPTION

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.

PERSON SPECIFICATION

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.

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification
Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careers@mhra.gov.uk
Benefits

Alongside your salary of £42,869, Medicines and Healthcare Products Regulatory Agency contributes £12,337 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

• Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays
• Privilege Leave: 1 day
• Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff
• Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay
• Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
• Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP’s Pension Service Centre directly on 0300 123 6666
• Flexible working to ensure staff maintain a healthy work-life balance
• Interest free season ticket loan or bike loan
• Employee Assistance Services and access to the Civil Service Benevolent Fund
• Eligibility to join the Civil Service Motoring Association (CSMA)
• Variety of staff and Civil Service clubs
• On-going learning and development

Things you need to know

SELECTION PROCESS DETAILS

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.

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 careers@mhra.gov.uk as soon as possible.
Closing date: Thursday 11th July 2024
Shortlisting Date: Friday 12th July 2024
Interview date: Monday 22nd July 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 careers@mhra.gov.uk
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 careers@mhra.gov.uk.
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, Mira.Mepa@mhra.gov.uk.
If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk
info@csc.gov.uk
Civil Service Commission
Room G/8
1 Horse Guards Road
London
SW1A 2HQ
Feedback will only be provided if you attend an interview or assessment.

NATIONALITY REQUIREMENTS

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements (opens in a new window)

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.