location_onLondon, UK
watch_later Posted: Nov 23, 2024
Skills Required
Nice To Have skills
Job Description
Canary Wharf, London
Job Summary
We are currently looking for a Clinical Study 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 19th February 2026. 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.
Job Description
What’s the role?
The Clinical Study Manager role offers an exciting opportunity to contribute to the UK Government’s premier data-driven research service. The post holder, as part of the Interventional Research (IR) team, will be responsible for delivering projects using the CPRD online study platform and will include configuration and testing of study specific modules; collecting metrics and reporting on progress against key performance indicators; working with clients and colleagues across CPRD to deliver studies on time and to target in compliance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs).
Key Responsibilities:
The Clinical Study Manager role offers an exciting opportunity to contribute to the UK Government’s premier data-driven research service. The post holder, as part of the Interventional Research (IR) team, will be responsible for delivering projects using the CPRD online study platform and will include configuration and testing of study specific modules; collecting metrics and reporting on progress against key performance indicators; working with clients and colleagues across CPRD to deliver studies on time and to target in compliance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs).
Key Responsibilities:
Our Successful Candidate Will:
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
Alongside your salary of £36,395, Medicines and Healthcare Products Regulatory Agency contributes £10,543 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.
We use the Civil Service Success Profiles to assess our candidates, find out more here.
Closing date: Thursday 12th December 2024
Shortlisting date: Wednesday 18th December 2024
Interview date: Monday 6th January 2025
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.
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, .
If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.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.
Security
Successful candidates must undergo a criminal record check.
People working with government assets must complete baseline personnel security standard (opens in new window) checks.
Successful candidates must undergo a criminal record check.
People working with government assets must complete baseline personnel security standard (opens in new window) checks.
Nationality requirements
This Job Is Broadly Open To The Following Groups:
Working for the Civil Service
The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.
We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commissions recruitment principles (opens in a new window).
The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.
The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.
The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.
We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commissions recruitment principles (opens in a new window).
The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.
The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.
Diversity and Inclusion
The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see the Civil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).
Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.
Contact point for applicants
Job 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 contact the Resourcing Team at , in the first instance. If you are not satisfied with the response you receive you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk - - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ
Job Summary
We are currently looking for a Clinical Study 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 19th February 2026. 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.
Job Description
What’s the role?
The Clinical Study Manager role offers an exciting opportunity to contribute to the UK Government’s premier data-driven research service. The post holder, as part of the Interventional Research (IR) team, will be responsible for delivering projects using the CPRD online study platform and will include configuration and testing of study specific modules; collecting metrics and reporting on progress against key performance indicators; working with clients and colleagues across CPRD to deliver studies on time and to target in compliance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs).
Key Responsibilities:
- Contribute to scoping project delivery
- Develop study plans and maintain study records
- Communicate project progress
- Support the delivery of projects using the CPRD online study platform
The Clinical Study Manager role offers an exciting opportunity to contribute to the UK Government’s premier data-driven research service. The post holder, as part of the Interventional Research (IR) team, will be responsible for delivering projects using the CPRD online study platform and will include configuration and testing of study specific modules; collecting metrics and reporting on progress against key performance indicators; working with clients and colleagues across CPRD to deliver studies on time and to target in compliance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs).
Key Responsibilities:
- Contribute to scoping project delivery
- Develop study plans and maintain study records
- Communicate project progress
- Support the delivery of projects using the CPRD online study platform
Our Successful Candidate Will:
- Have a healthcare or life sciences degree or equivalent work experience.
- Have project management experience and experience in producing reports and study documentation.
- Have previous employment experience in a clinical research operations role.
- Have experience in managing clinical research projects to a successful conclusion in line with UK clinical trials legislation and Good Clinical Practice (GCP).
- Have excellent verbal and written communication skills including the ability to communicate in a clear, succinct and engaging manner.
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
Alongside your salary of £36,395, Medicines and Healthcare Products Regulatory Agency contributes £10,543 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 MyCSPs 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
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.
Closing date: Thursday 12th December 2024
Shortlisting date: Wednesday 18th December 2024
Interview date: Monday 6th January 2025
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.
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, .
If you are not satisfied with the response you receive, you can contact the Civil Service Commission at: civilservicecommission.independent.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.
Security
Successful candidates must undergo a criminal record check.
People working with government assets must complete baseline personnel security standard (opens in new window) checks.
Successful candidates must undergo a criminal record check.
People working with government assets must complete baseline personnel security standard (opens in new window) checks.
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
Working for the Civil Service
The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.
We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commissions recruitment principles (opens in a new window).
The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.
The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.
The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.
We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commissions recruitment principles (opens in a new window).
The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.
The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.
Diversity and Inclusion
The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see the Civil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).
Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.
Contact point for applicants
Job Contact :
- Name : The Recruitment Team
- Email :
- Email :
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 contact the Resourcing Team at , in the first instance. If you are not satisfied with the response you receive you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk - - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ
