Aseptic Services Manager for Clinical Trials Aseptic Services Unit

Aseptic Services Manager for Clinical Trials

We are looking for a passionate and dynamic Aseptic Services Manager to join our Pharmacy Clinical Trials Aseptic Services Team at Oxford University Hospitals NHS Foundation Trust. The role focuses on clinical trials and will be part of the wider Pharmacy Clinical Trials Team. You will lead a range of aseptically dispensed clinical trial medicines while working in our unique and well‑established facility.

• Lead and manage the day‑to‑day service provided by CTAS, ensuring aseptic preparation of medicines complies with current guidance and best practice.
• Identify and implement initiatives to reduce financial costs and environmental impact of CTAS service.
• Maintain a good working knowledge of the Quality Assurance of Aseptic Preparation Services handbook and related guidance, and work with the Accountable Pharmacist and Deputy to review changes to standards.
• Ensure knowledge of the Medicines for Human Use (Clinical Trials) Regulation (EU Directive 2001/20EC), Human Medicines (EU Exit) Regulations 2019, and ICH GCP guidelines as applicable to investigational medicinal products.
• Ensure the preventative maintenance and environmental monitoring programme is conducted per SOPs, paperwork is reviewed, and deviations managed for compliance.
• Recruit, induct and manage staff; collaborate with the training team to maintain an effective and competent workforce.
• Foster a customer‑focused, patient‑centric culture within CTAS.

• Deliver cost‑effective high‑quality aseptic pharmaceuticals fit for their intended purpose.
• Maintain comprehensive knowledge of national legislation and recommendations from regulators (Department of Health, MHRA, NHS England, GPhC, RPS).
• Facilitate QA inspections, MHRA sponsor audits, and communicate regulatory information to resolve findings.
• Maintain the Pharmaceutical Quality System (PQS) and ensure SOP compliance.
• Ensure ongoing staff competency through validation programmes.
• Monitor internal and external errors/near‑misses and take corrective and preventative action.
• Participate in local, regional and national initiatives to advance aseptic preparation and research.
• Manage accurate financial records, invoicing and authorisation.
• Process Drug Alerts from the MHRA within required time frames.

• Pharmacy Technician or SMT Diploma.
• PIPC certification.
• PTQA or equivalent.

• Experience in aseptic services.
• Experience training and supervising staff.
• Knowledge of and ability to apply GMP and QA to aseptic services.
• Experience managing staff.
• Experience working in Clinical Trials.
• Experience working in ATMPs.

• Accurate and detail‑oriented.

• Capable of working under pressure.
• Ability to liaise, explain and convey difficult information to staff and service users.
• Strong teamwork and independence skills.

This post requires a Rehabilitation of Offenders Act (Exceptions Order) 1975 disclosure submission to the Disclosure and Barring Service.

• Contract: Permanent
• Working pattern: Full‑time
• Location: Clinical Trials Aseptic Services Unit, Churchill Hospital
• Salary: £47,810 to £54,710 per annum, pro rata
• Reference number: 321‑CORP‑7539857‑B7

Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country, offering a wide range of clinical services and serving as a base for medical education, training and research.