Clinical Trials Pharmacist

The Christie NHS FT is seeking a highly skilled and experienced Clinical Trials Pharmacist to join our team. As a key member of our multidisciplinary team, you will play a critical role in supporting the Christie Research 2030 programme, a transformational investment in cancer research over the next 6 years.

• Lead a high-quality professional pharmacy Clinical Trials service, optimising patient access to and outcomes from clinical trials, improving the overall patient experience.
• Ensure that pharmacy clinical trials services are provided in a safe, efficient manner, compliant with all relevant UK and EU legislation and professional regulations.
• Develop and implement strategies to improve health outcomes for patients using a holistic approach to care, ensuring the safe and effective use of medicine through provision of medicines-related aspects of patient care.
• Provide expert advice to the national Clinical Trials pharmacy advisory group, Trusts R&I Division and Clinical Trials Principal Investigators in respect of all aspects of IMP manufacture, procurement and supply.
• Lead, develop and be responsible for pharmacy clinical trials and experimental cancer medicines services across the Trust and the wider Cancer Network.
• Deputise for the Director of Pharmacy at the Trust R&I Divisional and Christie Research Executive Committee meetings, providing regular updates on pharmacy services, performance metrics and on developments with clinical trials and experimental cancer medicines.

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 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.

• To lead a high-quality professional pharmacy Clinical Trials service, optimising patient access to and outcomes from clinical trials, improving the overall patient experience.
• To strategically lead and co-ordinate the Clinical Trials pharmacy team in the provision of a safe, effective and efficient service in accordance with local and national standards and strategy.
• To contribute to improving health outcomes for patients using a holistic approach to care, ensuring the safe and effective use of medicine through provision of medicines-related aspects of patient care.
• To ensure that pharmacy clinical trials services are provided in a safe, efficient manner and are compliant with all relevant UK and EU legislation and professional regulations.
• To ensure that pharmacy clinical trials services are fully aligned to support the Trusts research strategy and the pharmacy service strategy.
• To lead Pharmacy support at MHRA GCP inspections ensuring access to documentation.
• To provide with expert advice to the national Clinical Trials pharmacy advisory group, Trusts R&I Division and Clinical Trials Principal Investigators in respect of all aspects of IMP manufacture, procurement and supply.
• Provide professional leadership to clinical trials pharmacy staff and manage the lead pharmacists, ensuring compliance with regulations and standards.
• To lead, develop and be responsible for pharmacy clinical trials and experimental cancer medicines services across the Trust and the wider Cancer Network.
• Deputise for the Director of Pharmacy at the Trust R&I Divisional and Christie Research Executive Committee meetings, providing regular updates on pharmacy services, performance metrics and on developments with clinical trials and experimental cancer medicines.
• To provide professional leadership for pharmacy Clinical Trials services to assure the Trust of compliance with the Human Medicines Regulations 2012 SI and the applicable SI including: Medicines for Human Use (clinical trials) Regulations 2004 and subsequent amendments; The Medicines for Human Use (Clinical Trials) and blood safety and quality (Amendment) Regulations 2008, SI ; EU Directive 2001/20EC, International Convention of Harmonisation (ICH) guidelines for Good Clinical Practice (GCP).
• Updates and advises the Director of Pharmacy and wider pharmacy senior management team on pharmacy clinical trial services and experimental cancer medicines providing assurance on compliance with legislation, capacity and capability.
• Act as the pharmacy expert on Advanced Therapy Medicinal Products used in clinical trials, contributing to their safe and efficient handling within the Trust and compliance with regulation and guidance.
• To use innovation to support effective patient outcomes, safety and experience aligned with relevant national agenda.
• To lead, undertake, supervise and publish research in specialist area of practice.

• Practice within the professional boundaries described by the General Pharmaceutical Council.
• Undertake annual professional revalidation comprising; continuing professional development (CPD) entries, reflective account and peer discussion.
• Follow legal, ethical, professional and employers codes of conduct.
• Undertake formal GCP and GMP training and maintain competency.
• To contribute to local, regional and national training initiatives for clinical trials and experimental cancer medicines.

• To be recognised as an expert within the speciality of clinical trials pharmacy, locally and nationally and/or internationally.
• Provide senior level expert advice to the Trust Research & Innovation Division, Chief Investigators & the Trust on Investigational Medicinal Products (IMPs) and take responsibility for their procurement, storage and handling on site.
• Act as the main pharmacy link to research stakeholder groups including the Experimental Cancer Medicines Team, the University of Manchester and the Manchester Cancer Research Centre.
• Oversee pharmacy governance arrangements for clinical trials and experimental cancer medicines, ensuring they are of appropriate quality for their intended use and introduced safely.
• Lead expert pharmacy support including the development of trust policy, protocols and SOPs on clinical trials.
• Compliance with legislation and guidance.
• Technical and regulatory assessment and advice.
• Ensure that staff handling clinical trials medication have the appropriate skills and expertise.
• Ensure robust links with specialist disease group and aseptic service pharmacy teams.
• Be responsible for Pharmacy working practices to assure the Trust of compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004 (EU Directive 2001/20EC), International Convention of Harmonisation (ICH) guidelines for Good Clinical Practice (GCP).
• Provide advice to all trust research stakeholders in respect of all aspects of CTiMP manufacture, procurement and use and of adherence to associated legislation.
• To maintain a comprehensive knowledge of national regulations and directives, legislation and recommendations from the Department of Health, the European Medicines Agency (EMA), the MHRA, NHS England and the General Pharmaceutical Council and Royal Pharmaceutical Society relating to CTiMPs, ATMPs and GCP. To be responsible for the impact of changes to these standards and implementing change where required.
• Provide expert and management support for MHRA GCP inspections, other national regulatory bodies and sponsor inspections, collaborating and communicating complex regulatory information to ensure that action is undertaken to resolve any findings.
• Ensure that clinical trials and advanced therapy medicinal products services are integrated into the pharmacy clinical governance agenda and play a lead role in the agenda and work of the Pharmacy governance programme.
• To appropriately manage difficult and ambiguous problems, managing uncertainty, and to make decisions with limited information.