Deputy Accountable Pharmacist for Clinical Trials Aseptic Services

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Clinical Trials Aseptic Services
To deputise for the Accountable Pharmacist responsible under the Section 10 exemption of the  Medicines Act and in accordance with current guidance and best practice, as detailed but not limited to those set out, in Quality Assurance of Aseptic Preparation Services (QAAPs) handbook.

Alongside the Accountable Pharmacist, and the Aseptic Services Manager to be responsible for the management, leadership and co-ordination of a Clinical Trials Aseptic Service and the provision of selected high risk injectable medicines to all Divisions within the Trust.

To be responsible for the release and distribution of aseptically prepared products from CTAS and the training of authorised pharmacists.

To manage and provide expert advice to support to Aseptic Unit Manager to ensure that the facility and staff deliver to QAAPs and ICH-GCP standards for dispensing aseptically prepared doses.

To be responsible for reviewing the impact of changes to QAAPS/GMP standards and implementing change where required.

To provide cost-effective delivery of high quality aseptic pharmaceuticals, which are fit for their intended purpose to patients of the Trust, and other external customers of the service.

To participate in identifying and implementing initiatives as appropriate to reduce the financial costs and the environmental impact of CTAS service, through QI approach.

To set-up new trials that require aseptic preparation of doses in accordance with local procedures and GMP and ICH-GCP regulations, and review trials that have been set-up by pharmacy clinical trials colleagues for final Pharmacy approval.

To provide expert advice on matters relating to the use of injectable medicines and specialist technical pharmacy knowledge to all Divisions within the Trust, as well as to the University of Oxford research teams.

Alongside the Accountable Pharmacist assess IMPs and other injectable products for the most suitable preparation area.

Be responsible for the writing, amending and reviewing of worksheets.

Initiates, advises and contributes to research and development of new aseptic preparation methods (including the introduction of new technology and novel products) of work; to publish findings as appropriate.

ATMPs
To work with the Accountable Pharmacist to establish best practice for the handling of ATMPs in the aseptic unit or a biological safety cabinet. To support commissioning of any new equipment and facilities.

 Work with the clinical areas and the local biological safety officers to establish best practice for the handling of ATIMPs in the clinical areas.

 Alongside the Consultant Pharmacist for cancer and ATMPs act as the subject matter expert for ATMPs in the Trust.

To set-up new ATMP trials in accordance with local procedures and GMP, HSE and ICH-GCP regulations, and review trials that have been set-up by pharmacy clinical trials colleagues for final Pharmacy approval.

Work with the Consultant Pharmacists and Divisional Lead Pharmacists to ensure appropriate governance arrangements are in place for the prescribing, handling and administration of ATMPs.

Management
To line manage staff and undertake all aspects such as appraisals, manage leave, training.

As senior member of the team, manage, support and supervision the team and support effective communication and be pro-active.

To ensure own professional development, registration, annual appraisal and maintain core training.

Uphold the values of the trust.

If you are interested in this role but don't have the required experience or knowledge, then we can offer as a progression post from B7 to B8a. Please get in touch for an informal chat if you have any questions.