Job summary
Clinical Trials and Innovative Medicines Lead Pharmacist -Band 8b
Average of 37.5 hours/week across a 7 day working rota (with a maximum weekend commitment of 1 in 4)
This exciting post has been developed following investment in Pharmacy to support Clinical Trials.
We are looking to recruit an experienced and highly motivated individual to join our well established team in Pharmacy Technical Services to lead the Clinical Trials Service and develop the service for Advanced Therapy Investigational Medicinal Products (ATIMPs) at UHNM.
This post will be part of the leadership team in Technical Services and support the maintenance of the MHRA Manufacturer's 'Specials' Licence
The MHRA licenced 'Specials' pharmacy manufacturing unit is based at the Royal Stoke University Hospital and is a modern purpose-built unit within the hospital. The service encompasses aseptic, chemotherapy, pre-pack (over labelling and repackaging products) supplying both the Trust and external organisations. As a department we constantly strive to re-engineer our services to improve our delivery of patient focused pharmaceutical care and customer satisfaction.
Main duties of the job
Main duties
- To lead, manage, develop and be responsible for pharmacy clinical trials services including Advanced Therapy Investigational Medicinal Products (ATIMPs) at UHNM
- To provide expert advice on pharmaceutical aspects of clinical trials and ensure that all legal and statutory requirements are met, both within and outside pharmacy
- Ensure pharmacy clinical trials services are fully aligned to support the Trust's research strategy and the pharmacy strategy. To represent pharmacy providing updates on pharmacy services and capacity, performance metrics and on developments with ATIMPs in the appropriate forums
- Take leadership and management responsibility for Technical Services, in collaboration with and complimenting the role of Technical Services Production Manager
- Prepare for, and participate in, any inspections and audits undertaken by the Medicines and Healthcare Products Regulatory Agency (MHRA) or other regulatory authority. This will include the development of any remedial action plans and ensuring that these are delivered in a timely manner.
About us
University Hospitals of North Midlands NHS Trust is one of the largest and most modern in the country. Based across two sites, Royal Stoke in Stoke-on-Trent and County Hospital in Stafford, we are proud to serve around three million people and we're highly regarded for our facilities, teaching and research. We are the specialist centre for major trauma for the North Midlands and North Wales.
All of our employees make a valuable contribution regardless of role here at UHNM and we are proud of our wide range of development packages aimed at ensuring that everyone has the opportunity to fulfil their true potential.
UHNM create and encourage a culture of inclusion, providing equal opportunities for career development that are fair and transparent. We are committed to being a diverse and inclusive employer and foster a culture in which all staff feel valued and respected. In return we ask all of our employees to make a commitment to the values, co-created by or staff, patients and carers, and that unite us as a Trust.
At University Hospitals of North Midlands NHS Trust we know that investing in, supporting and developing our staff has a direct impact on the quality of care that we deliver. Our employees are as important as our patients and the population that we serve.
Job description
Job responsibilities
This is a great time to be a part of the Pharmacy Technical Services Team at UHNM.
For further information please see the attached job description
Job description
Job responsibilities
This is a great time to be a part of the Pharmacy Technical Services Team at UHNM.
For further information please see the attached job description
Person Specification
Essential Qualifications
Essential
- Masters degree in Pharmacy (MPharm) or equivalent
- Registered with General Pharmaceutical Council
- Commitment and evidence of professional updating and formal continuous professional development (CPD)
- Postgraduate Clinical Pharmacy Diploma / MSc or equivalent qualification
- Postgraduate qualification in Genomic medicine
- Eligible to be named as Head of production on the MHRA licence
- Releasing Officer in a MHRA Licensed Unit or eligible to undertake this training
- Good Clinical Practice (GCP) certification
Desirable
- PTQA qualification
- Member of the RPS
- Formal management and / or leadership qualification
Knowledge, Skills, Training and Experience
Essential
- Extensive hospital pharmacy experience post registration
- Recent, extensive experience of working in clinical trials
- Recent, extensive experience of working at a senior level within a pharmacy manufacturing unit or a related industry.
- Experience of external inspections including MHRA and CQC
- Knowledge and understanding of the EU Clinical Trial Directive
- Experience of managing and developing a service
- Knowledge and experience of capacity and contingency planning and monitoring.
- Experience of production facility management and monitoring.
- High standard of oral and written (including report writing) communication skills with attention to detail
- Good knowledge of the medicines safety, risk management and governance agenda and it's application to the clinical role
- Competent in the use of various computer systems and knowledge of the digital medicines agenda
- Management experience and / or experience of staff recruitment and appraisal
- Experience of procuring medicines and stock control
Desirable
- Experience of writing business case
- Evidence of involvement in pharmacy practice based research and / or audit
Person Specification
Essential Qualifications
Essential
- Masters degree in Pharmacy (MPharm) or equivalent
- Registered with General Pharmaceutical Council
- Commitment and evidence of professional updating and formal continuous professional development (CPD)
- Postgraduate Clinical Pharmacy Diploma / MSc or equivalent qualification
- Postgraduate qualification in Genomic medicine
- Eligible to be named as Head of production on the MHRA licence
- Releasing Officer in a MHRA Licensed Unit or eligible to undertake this training
- Good Clinical Practice (GCP) certification
Desirable
- PTQA qualification
- Member of the RPS
- Formal management and / or leadership qualification
Knowledge, Skills, Training and Experience
Essential
- Extensive hospital pharmacy experience post registration
- Recent, extensive experience of working in clinical trials
- Recent, extensive experience of working at a senior level within a pharmacy manufacturing unit or a related industry.
- Experience of external inspections including MHRA and CQC
- Knowledge and understanding of the EU Clinical Trial Directive
- Experience of managing and developing a service
- Knowledge and experience of capacity and contingency planning and monitoring.
- Experience of production facility management and monitoring.
- High standard of oral and written (including report writing) communication skills with attention to detail
- Good knowledge of the medicines safety, risk management and governance agenda and it's application to the clinical role
- Competent in the use of various computer systems and knowledge of the digital medicines agenda
- Management experience and / or experience of staff recruitment and appraisal
- Experience of procuring medicines and stock control
Desirable
- Experience of writing business case
- Evidence of involvement in pharmacy practice based research and / or audit
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Employer details
Employer name
University Hospital of North Midlands NHS Trust
Address
Royal Stoke University Hospital
Newcastle Road
Stoke-on-Trent
ST4 6QG
Employer's website
https://www.uhnm.nhs.uk (Opens in a new tab)
