Application Support Coordinator

Job Description

We are currently looking for an Application Support Coordinator to join our Clinical Investigations & Trials function within the Science, Research & Innovation group.

This is a full-time opportunity, on a permanent basis. 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 8 days per month working on site to enable 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.

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 Science, Research and Innovation Group delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which will balance innovation against sustainability and affordability. It is divided into 6 sub-Groups, Innovation Accelerator, Clinical Investigations and Trials, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety.

The Clinical Investigations and Trials function ensure the efficient, pragmatic, proportionate and patient-centred advice for, and assessment of, clinical investigations into the performance and safety of medical devices and diagnostics as well clinical trials of investigational medicinal products.

What’s the role?

This role will be responsible for managing internal databases to ensure that accurate and up-to-date information is maintained and available to internal stakeholders and the public, where applicable. In addition, you would be responsible for liaising with Unit colleagues and the Health Research Authority on maintaining and generating performance measures.

The role will also require assisting the Application Specialists in the handling of clinical trial and investigation applications, you will be required to provide data handling support in the downloading, logging and allocation of clinical investigation applications, as well as processing the associated fees. You will also be responsible for contacting external expert assessors where appropriate.

Key Responsibilities

1. Manage the agency database(s) and check consistency between public registers, Appian systems and other Agency systems (where relevant), to ensure appropriate information for clinical trials and clinical investigations is available.
2. Download from IRAS and ensure all documentation is correct for clinical investigation applications, inputting applications on the Agency databases and supporting the Application specialists with allocation of both clinical trials and clinical investigation applications and monitoring of timelines.
3. Contact external experts for clinical investigation applications, providing them with the documentation necessary for their reviews, answering any questions and processing the associated fees.
4. Generate performance measures for UK trial, and investigation registration and summary results posting. Work with the application specialists in presentation of Unit metrics for reports and enquiries as required.

Who are we looking for?
Our Successful Candidate Will Have

1. A degree in Life Sciences or other relevant degree, or appropriate work experience in the pharmaceutical, medical sector and/or regulatory sectors.
2. Proven experience of working in a busy team demonstrating effective management, organisation and delegation skills.
3. Proven ability to gather and analyse information (eg from MS office or business objects), and to identify and report clearly on pertinent issues or problems.
4. A positive and focused attitude to achieving outcomes, despite any setbacks.

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!

The Selection Process

We use the Civil Service Success Profiles to assess our candidates.

1. 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.
2. Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.

In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of Experience - proven experience of working in a busy team demonstrating effective management, organisation and delegation skills.

Closing date: 30 April 2025

Shortlisting date: by 9 May 2025

Interview date: 28 – 30 May 2025

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