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Job summary

Main area
317 Pharmacy Northern Alliance - RVI
Grade
Band 7
Contract
Fixed term: 39 months (until 31 March 2028)
Hours
Full time - 37.5 hours per week
Job ref
317-2024-41-021
Employer
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Employer type
NHS
Site
Royal Victoria Infirmary
Town
317 02 Royal Victoria Infirmary
Salary
£46,148 - £52,809 per annum
Salary period
Yearly
Closing
05/11/2024 23:59
Interview date
21/11/2024

Employer heading

The Newcastle upon Tyne Hospitals NHS Foundation Trust logo

ATIMP Trials Manager

Band 7

Newcastle Hospitals NHS Foundation Trust is one of the busiest and largest NHS foundation trusts in the country, with around 15,000 staff and an annual budget of £1.6 billion.

We have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.

We’re in the top five providers of specialised health services in the country, supporting people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders. 

Our staff oversee around 6,500 patient contacts each day, delivering high standards of healthcare.

We are committed to promoting equality and diversity and recognise the benefit in providing an inclusive environment. We value and respect the diversity of our employees and aim to recruit a workforce which reflects the communities we serve, and is equipped to deliver the best service to our patients. We welcome all applications irrespective of people’s race, disability, gender, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups.

Newcastle Hospitals are proud to be one of the exemplar organisations across the NHS on sustainability, with a long history of delivering Sustainable Healthcare in Newcastle (Shine) and the first healthcare organisation in the world to declare a climate emergency. Our strategy includes commitments to being Net Zero by 2030, for our direct carbon footprint, and Net Zero by 2040 for our footprint plus. Delivering these ambitions will not be possible without the help, support and action of every single member of our team.

Job overview

An exciting opportunity has arisen to make a significant impact to the growing portfolio of advanced therapy clinical trials in the Newcastle Hospitals by leading and supporting the set-up, approvals and delivery of ATIMP studies across several disease areas. Newcastle Hospitals is one of the leading centres in the UK for facilitating advanced therapy research and the implementation of licensed cell and gene therapy products.

This post has been enabled by the Northern Alliance Advanced Therapy Treatment Centre (NAATTC), As well as making a significant impact to the patients in Newcastle recruited to advanced therapy trials you will also support the wider aims of the ATTC network in addressing some of the complex local and national barriers that exist.
 
You will be based within the NIHR Clinical Research Facility and will co-ordinate and oversee ATIMP research activity trust wide, bringing together colleagues from different areas to accelerate setup and implementation of these complex and exciting trials. You will have the opportunity to work with clinical, regulatory and scientific teams working together to increase our activity in advanced therapeutics. 

  • Interview Date Thursday, 21 November 2024
  • 37 Hours 30 Minutes/Week
  • You will be redirected to Trac to apply for the vacancy.  Please expand the job details section and read all of the information before applying for the vacancy

Main duties of the job

  • Act as a main point of contact for clinical trials involving Advanced Therapy Investigational Medicinal Products (ATIMPs), providing advice, practical support and guidance during the setup, approvals and implementation process. 
  • Responsible for improving delivery, accelerate the setup and increase a broad portfolio of ATIMP studies.
  • Co-ordinate and oversee ATIMP research activity trust wide, bringing together colleagues from different areas to accelerate setup and implementation of trials.
  • Participate in the design and delivery of relevant and specific ATIMP education programs and will identify and meet the training needs of research support staff.
  • Chair an operational group cross-department with the aim of tracking, reporting, and accelerating the setup of ATIMP trials. 
  • Will support the delivery of the Northern Alliance Advanced Therapies Treatment Centre (NA-ATTC) by supporting the ATTC network’s ATIMP clinical trial programme, providing reporting and data collection as required and participating actively in local and national meetings.

Working for our organisation

Newcastle Hospitals NHS Foundation Trust is one of the busiest, largest and most successful teaching NHS foundation trusts in the country, with around 16,000 staff and an annual income of £1 billion.

We have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.

We’re also proud to be the second largest provider of specialised services in the country. This means we support people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders.

Our staff oversee around 2 million patients ‘contacts’ each year, delivering high standards of healthcare.

Please see attached information on what Staff Benefits we have to offer at our Trust.

We are committed to promoting equality and diversity and recognise the benefit in providing an inclusive environment. We value and respect the diversity of our employees and aim to recruit a workforce which reflects the communities we serve, and is equipped to deliver the best service to our patients. We welcome all applications irrespective of people’s race, disability, gender, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups.

 

 

Detailed job description and main responsibilities

  • Working with the multi-disciplinary team, the post holder will be responsible for the coordination of resource and leading activity to improve delivery, accelerate the setup, and increase a broad portfolio of ATIMP studies.
  • Will co-ordinate and oversee ATIMP research activity trust wide, bringing together colleagues from different areas to accelerate setup and implementation of trials.
  • Will participate in the design and delivery of relevant and specific ATIMP education programs and will identify and meet the training needs of research support staff. This will include the delivery of any education and training programs developed by the NA-ATTC ATIMP clinical trial programme.
  • Provide governance expertise and support, liaising closely with the NJRO, as required.
  • To support in the delivery of agreed performance targets.
  • In conjunction with the multidisciplinary team the post holder will facilitate the delivery of ATIMP clinical research in line with contractual agreements.
  • Work closely with Finance and ensure budgetary management within teams, including appropriate study costing and rigorous recording of all research activity to enable timely invoicing.
  • To lead or contribute to cross-specialty and cross-directorate ATMIP projects to deliver improvement, objectives or the strategic priorities and vision of the Research Directorate and Trust.

As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.

Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate. The method of payment is a salary deduction from your first month’s pay.

Person specification

Qualifications & Education

Essential criteria
  • Educated to degree level in a relevant subject
Desirable criteria
  • Educated to degree level in a relevant subject
  • Management qualification
  • Leadership qualification

Knowledge & Experience

Essential criteria
  • Knowledge and understanding of UK research regulations
  • Significant experience of conducting and managing clinical trials, including setup and delivery
  • Knowledge and understanding of relevant local, regional and national NHS policies and frameworks relevant to the role
  • Experience of clinical research study budgetary oversight, costing and financial trials management
  • Management experience with developed skills including change management, team leadership and team development to master’s level equivalent
  • Ability to demonstrate extensive knowledge and experience of working to ICH GCP standards
Desirable criteria
  • Advanced therapies research specific knowledge and experience
  • Experience of the setup and management of Advanced Therapy Investigational Medicinal Product (ATIMP) clinical trials
  • Experience of working with research funders, including industry and NHS

Skills & Abilities

Essential criteria
  • Excellent communication skills and ability to facilitate collaborative working relationships
  • Highly skilled negotiator
  • IT skills including competence in standard PC packages (e.g. word, Excel, Outlook
  • Ability to work as part of the multi-disciplinary team to facilitate successful study delivery through all stages of the research process

Employer certification / accreditation badges

We are a Living Wage EmployerVeteran AwareApprenticeships logoNo smoking policyPositive about disabled peopleAge positiveInvestors in People: GoldArmed Forces Covenant Gold AwardRIDI Awards Finalist 2021Mindful employer.  Being positive about mental health.Disability confident employerStonewall Gold 2022Better Health at Work Award - Maintaining ExcellenceDefence Employer Recognition Scheme (ERS) - Gold

Documents to download

Apply online now

Further details / informal visits contact

Name
Jonathan Stoddart
Job title
Research Business Manager CRF
Email address
[email protected]
Telephone number
0191 9177263
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