Aseptic Services Manager for Clinical Trials Aseptic Services Unit
NHS AfC: Band 7
Main area Pharmacy Aseptic Services Grade NHS AfC: Band 7 Contract Permanent Hours Full time - 37.5 hours per week (1 in 6 weekends) Job ref 321-CORP-7539857-B7
Site Clinical Trials Aseptic Services Unit (CTASU), Churchill Hospital Town Headington, Oxford Salary £47,810 - £54,710 per annum pro rata Salary period Yearly Closing 01/02/2026 23:59 Interview date 09/02/2026
Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. The Trust comprises four hospitals – the John Radcliffe Hospital, Churchill Hospital, Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury.
Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community. We call this Delivering Compassionate Excellence and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence.
Job overview
Hi I'm Emma, Head of Pharmacy Clinical Trials Aseptic Services Unit. We are looking for a passionate and dynamic Aseptic Services Manager to join our Pharmacy Clinical Trials Aseptic Services Team for our unique and well‑established facility. The role is dedicated to clinical trials and you will work as part of the wider Pharmacy Clinical Trials Team. In your new role you will have the opportunity to use your knowledge and experience of working in aseptics in the UK and build on this to deliver a range of aseptically dispensed clinical trial medicines.
Main duties of the job
* Lead and manage the day‑to‑day service provided by CTAS, ensuring aseptic preparation of medicines is run in accordance with current guidance and best practice.
* Identify and implement initiatives to reduce the financial costs and environmental impact of the CTAS service.
* Maintain good working knowledge of the Quality Assurance of Aseptic Preparation Services handbook and yellow cover guidance documents from SPS, reviewing impact of changes with the Accountable Pharmacist and Deputy and implementing change where required.
* Have good working knowledge of the Medicines for Human Use (Clinical Trials) Regulation (EU Directive 2001/20EC), Human Medicines (EU Exit) Regulations 2019 and the International Conference on Harmonisation GCP Guideline (ICH GCP), as applicable to dispensing Investigational Medicinal Products for clinical trials or other products.
* Ensure the preventative maintenance and environmental monitoring program is undertaken per SOPs, paperwork is received and reviewed and deviations are managed to ensure compliance with the standards.
* Be responsible for the ongoing recruitment of staff, induction and management, and collaborate with the training team to ensure an effective and competent workforce.
* Ensure CTAS and its staff operate to standards of excellence in customer care with a strong patient focus.
* Facilitate NHS QA inspections, MHRA, sponsor audits where required, communicating complex regulatory information to resolve any findings.
* Maintain the Pharmaceutical Quality System (PQS) and ensure staff work according to SOPs detailed in the PQS.
* Support ongoing validation programmes to demonstrate ongoing competency.
* Monitor and record internal and external errors/near misses, taking corrective and preventative action as part of the Trust’s Incident Monitoring Programme.
* Participate as required at local, regional and national levels to support advancement of Pharmacy Aseptic preparation and associated research.
* Be aware of Health and Safety regulations applicable to an aseptic unit, including manual handling, First Aid, COSHH and the Biocidal Products Regulation.
* Maintain accurate financial records, including invoicing, checking of invoices and authorisation of invoices for payment.
* Process Drug Alerts received from the Medicines and Healthcare Regulatory Authority (MHRA) within required time frames.
Person specification
Qualifications
* Pharmacy Technician or SMT Diploma
* PIPC
* PTQA or equivalent
Experience
* Experience in aseptic services
* Experience of training and supervision
* Knowledge of and ability to apply GMP and QA to aseptic services
* Experience of managing staff
* Experience working in Clinical Trials
* Experience working in ATMPs
Personal Skills
* Accurate work and attention to detail
Behavioural
* Capable of working under pressure
* Ability to liaise, explain and convey difficult information and messages to all staff and service users
* Ability to work in a team and independently
COVID-19:
The COVID-19 vaccination remains the best way to protect yourself, your family, your colleagues and our patients from the virus when working in our healthcare settings. Whilst COVID-19 vaccination is not a condition of employment, we do encourage staff to get vaccinated. If you are unvaccinated there is helpful advice and information at the Oxfordshire County Council website where you can also find out more about how to access vaccination.
Fraud Prevention
Fraudulent recruiters have been using social media platforms to dupe potential job seekers into divulging personal and financial information. Sophisticated frauds, involving grooming of targeted individuals, may present a fake job interview, either over the phone or via WhatsApp, and send fraudulent follow‑up correspondence offering job positions. All communication about jobs at Oxford University Hospitals will come from ‘Trac’ or via an ouh.nhs.uk email address. All meetings and interviews will be scheduled on Microsoft Teams from a verified OUH email account.
Next Steps
Please read the job description and person specification carefully and ensure your supporting statement reflects these criteria. Candidates selected for interview will be contacted after the short‑listing process, usually within 2 weeks. The majority of correspondence will be via the e‑recruitment system; therefore you should check your emails regularly, including junk mail folders.
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