Consultant Pharmacist, Cancer Clinical Trials
- NHS
- Full Time
- Manchester
- 74290.00 - 85601.00 a year
Job Description
Job summary
CONSULTANT PHARMACIST, CLINICAL TRIALS & EXPERIMENTAL CANCER MEDICINES
This innovative post is a critical part of the multidisciplinary team that will support The Christie Research 2030 programme, a transformational investment in cancer research over the next 5 years.
Our ambition of research-embedded healthcare will deliver better outcomes and reduce health inequalities for all patients. We plan to learn from every patient and enable every patient to take part in research.
Aligned to The Christie Strategy we will realise the potential of The Paterson Research Building, home to one of the largest concentrations of scientists, doctors and nurses in Europe to bring tomorrow's treatments to patients faster and enable Christie leaders to drive seamless integration of research with clinical care.
The diverse needs of 30,000 new patients annually will be met through an inclusive, learning healthcare system spanning next generation diagnostics, treatments, digital and real-world evidence research. We intend to double and then treble the number of patients participating in research, bringing innovations for better outcomes to The Christie.
Main duties of the job
The postholder will lead a high-quality professional pharmacy Clinical Trials service, supported by an experienced and growing team, optimising patient access to and outcomes from clinical trials and improving the overall patient experience.
The postholder will ensure that pharmacy clinical trials services are provided in a safe, efficient manner, compliant with all relevant UK and EU legislation and professional regulations and fully aligned with the Trust's research strategy and the pharmacy service strategy.
The postholder will 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. In addition to the clinical trials workload, the postholder will provide leadership for Pharmacy's own rapidly-growing portfolio of practice research.
About us
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 Systemic Anti-Cancer Therapy on site, through 14 other satellite units and at patients' homes; radiotherapy at one of the largest radiotherapy departments in the world; highly specialist surgery for complex and rare cancer; and a wide range of clinical support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years.
We already run one of the largest clinical trial units in Europe, with over 550 of the Trust's 800+ active trials portfolio currently involving CTIMPs, supported by our large and busy clinical trials and aseptic unit teams. Between now and 2030 we are aiming to double, then triple, the number of patients offered access to a clinical trial. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
Job responsibilities
DUTIES AND RESPONSIBILITIES
Key responsibilities
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 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 No.1916 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 No.941; 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.
In line with the National Profiles for Pharmacy, produced by NHS Employers, the consultant pharmacist post requires the postholder to:
a. Be responsible for leading and delivering highly specialist pharmacy service; undertake relevant risk management and ensure compliance with medicines legislation
b. Provide expert advice on pharmaceutical matters in specialist field
c. Lead and develops clinical audit; co-ordinate and undertake research; provide specialist training
Statutory Professional Responsibilities
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.
Expert professional practice
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 ...
