We are looking for a for a highly motivated, dynamic Pharmacy Technician to join our Clinical Trials team as our Quality Systems Lead.
The Christie is one of the largest oncology Trusts in the UK with an international reputation for clinical excellence, research, and development. This is a unique opportunity to work with us and contribute to the challenging and rewarding specialty of oncology pharmacy.
You will also work closely with other members of the team to ensure that Christie patients have access the latest development of oncology/haematology investigational medicines. You will form an integral part of the clinical disease teams and work closely alongside research teams. The Pharmacy Department are also supporting the large-scale collaborative project alongside several research partners and have strong links with the University of Manchester.
• To support the development and implementation of new systems of working resulting in improved service quality and efficiency.
• To function as project lead to delegated service improvement initiatives within clinical trials, e.g., application updates.
• To manage the clinical trials dispensary, ensuring safe delivery of clinical medicines to patients.
• Be part of the Pharmacy Clinical Trials divisional management team, and to support the Director of Pharmacy in the overall provision of a safe and effective pharmacy service to the Trust.
• Provide professional input and knowledge in the management of clinical trial material in the Trust and to ensure that all trials are conducted in accordance with the highest possible standards, and in compliance with the principles of International Conference of Harmonisation Good Clinical Practice Guidelines (ICH-GCP), Good manufacturing Practice (GMP), the Research Governance Framework for Health & Community Care (2001) and the Medicines for Human Use (Clinical Trials) Regulations 2004.Monitor the standard of professional work undertaken by clinical trial pharmacy technicians, assistants and PTPTs in accordance with local and any national competency frameworks.
• Maintain a Clinical Trial Pharmacy Technician role for study set-ups and accuracy checking.
The Christie is one of Europe’s leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country.
We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years.
We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
1. Clinical trial responsibilities:
• To develop and implement new systems of working resulting in improved service quality and efficiency.
• To function as project lead to delegated service improvement initiatives within clinical trials, e.g., application updates.
• To support the development and implementation of new systems of working resulting in improved service quality and efficiency
• To support with reporting, investigating, and actioning of DATIX incidents relating to clinical trials medicines, within area of practice.
• To lead on the investigation of near misses within the Clinical Trials Pharmacy and work alongside the trials pharmacists to analyze data and contribute to risk management.
• Ensures a robust stock management of drugs within clinical trials is maintained and reviewed to ensure minimum drug wastage.
• To provide technical management of clinical trials medication product recalls (MHRA or sponsors), defects and temperature excursions, and oversight of stock control.
• To work with R&I Quality team by proposing solutions to identified weaknesses and/or inefficiencies in the delivery of Clinical Trials within the scope of knowledge/expertise.
• To maintain systems and processes to ensure that clinical trial related activity is conducted in accordance with the UK Policy Framework for Health and Social Care Research, ICH GCP guidelines, Medicines for Human Use (Clinical Trials) Regulations 2004 and the EU directive, along with any other local or legal/regulatory requirements.
• Support the Chief Technician and Clinical Trials Pharmacists with internal and external audits and regulatory inspections by the Medicines and Health Regulatory Authority (MHRA) and implement recommendations and corrective and preventative actions.
• To assist in monitoring the standard of professional work undertaken by the pharmacy technicians in accordance with local and any national competency frameworks.
• To develop, implement and monitor compliance with standard operating procedures (SOPs) pertaining to the Clinical Trials Pharmacy Department, within the scope of knowledge/expertise.
• To support the Chief Technician and Lead Pharmacist for Clinical Trials in the development, implementation and monitoring of the technician and assistant’s input to Clinical Trial services at The Christie NHS Foundation Trust.
• To assist the clinical trials pharmacist team in the set-up and management of clinical trials within one or more nominated disease groups, including the assembly and maintenance of pharmacy site files, as required. Ensure all paperwork is complete and retained for future requirements relating to drug recalls.
• To provide professional input and knowledge in the management of clinical trial material in the Trust and to ensure that all trials are conducted in accordance with the highest possible standards, and in compliance with the principles of GCP (Good Clinical Practice), Good Dispensing Practice and Good Manufacturing Practice
• To be part of the Trusts R&I and clinical trials team and provide pharmaceutical knowledge and support to staff in the Trust participating in research and trials.
• Support the delivery of clinical trials to patients by acting as a certified accredited checking technician, supporting the final check of clinical trial prescriptions.
• To represent the department in internal and external meetings, as relevant to the job specification.
• Any other reasonable duties as requested by the Chief Clinical Trials Pharmacy Technician or Lead Pharmacist for Clinical Trials.
2. Managerial responsibilities:
• To manage the clinical trials pharmacy technicians, assistant technical officers and administrative staff and ensure their compliance to defined performance standards and key performance indicators.
• To lead, direct and motivate staff, acting as a role model and mentor for clinical trials technical and administrative teams.
• To oversee, the recruitment of technical and assistant staff into the clinical trials service in accordance with the Trust’s recruitment and selection policies and induction programmes.
• To be responsible for and to oversee the management of pharmacy technical, assistant, and administrative staff working in the clinical trials division. Ensure that staff
1. Have at least one Performance and Development Review annually
2. Have their sickness managed in accordance with Trust policies and in particular the Management of Attendance Policy
3. Manage the administration processes for temporary cover for annual leave, vacant posts, and exceptional cover, for example, for sickness or maternity leave ensuring a smooth transition is always maintained.
4. Attend appropriate meetings ensuring the views of the clinical trial department are conveyed and actions are implemented. Work closely with other managers to introduce new processes and improvements within the department, division and across the Trust.
5. Have their education and training needs regularly assessed, that all training is monitored, and that staff have the requisite skills (or are working towards achieving them) required for the jobs for which they are employed.
• To complete and monitor delegated rota for the technical clinical trials service, to ensure the most effective deployment of the clinical trial pharmacy team.
• To liaise with the Chief Technician and Lead Pharmacist for Clinical Trials in the implementation of changes to the clinical trials service following national and local drivers.
• To act independently within the broad framework of technical pharmacy policy and procedure.
• To be responsible for the maintenance of the pharmacy clinical trials equipment and assets via the Trust replacement program.
• To communicate operational service procedures to ward and department personnel gaining co-operation for on-going compliance.
• To lead, direct and motivate staff, acting as a role model and mentor for clinical technicians. To act as a professional role model and develop positive relationships with key personnel.
• To develop, monitor and integrate written policies/guidelines and procedures on pharmacy clinical trials.
3. Professional responsibilities:
• To be aware of the national drivers for change relating to clinical pharmacy trial services.
• To maintain a commitment to continuing professional development, undertaking further learning opportunities as identified through appraisal and self-assessment against professional frameworks.
• To undertake clinical audit, with particular emphasis on clinical trials pharmacy services liaising with the Lead clinical trials pharmacist and pharmacy audit leads.
• To participate in dispensary duties as required, maintaining a working knowledge in current drug usage and dispensary procedures.
• To undertake the accredited checking of dispensed prescriptions.
• To participate in other departmental duties that whilst not specifically detailed in this job description, are consummate with the post banding.
• To participate in the weekend/Bank Holiday service.
• To maintain safe systems of work in accordance with the relevant Medicines Act and Health and Safety legislation, and to ensure that any defects which may affect Safety at Work are brought to the attention of the appropriate manager.
4. Education and development responsibilities:
• To assist in the professional development of pharmacy technical roles.
• To function as a Practice Supervisor for technicians and pharmacy assistants, facilitating their training and professional development.
• Is responsible for participation in CPD and maintaining clinical knowledge with an up-to-date portfolio and actively facilitates ongoing CPD for all post registration pharmacy technicians.
• To attend and ensure attendance at department training sessions as required for professional and personal service development.
• To attend mandatory training sessions as required for professional/personal/service development and ensure the attendance of all technical staff within the ward divisions.
This advert closes on Friday 10 Jan 2025
Proud member of the Disability Confident employer scheme
Disability Confident
About Disability Confident
A Disability Confident employer will generally offer an interview to any applicant that declares they have a disability and meets the minimum criteria for the job as defined by the employer. It is important to note that in certain recruitment situations such as high-volume, seasonal and high-peak times, the employer may wish to limit the overall numbers of interviews offered to both disabled people and non-disabled people. For more details please go to Disability Confident .