Job summary
An exciting opportunity has arisen for an enthusiastic and self-motivated pharmacy technician to join the Pharmacy Clinical Trials team as a Band 6 Lead Project Manager, Clinical Trial Manufacturing & Supplies. The post holder will work closely with the pharmacy clinical trials team to support the delivery of a high-quality clinical trial manufacturing and supplies service to non-commercial and commercial sponsors, contract research organisations (CROs), and Clinical Trial Units (CTUs) in accordance with current UK Clinical Trials Regulations and all amendments, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) guidelines and department procedures. The post holder will support the set-up, maintenance, manufacturing, packaging, storage and delivery, close-down, archiving and invoicing of clinical trials. Potential candidates will be qualified pharmacy technicians with demonstrable post-qualification hospital pharmacy experience including dispensary services and aseptic manufacture.
Main duties of the job
The post holder will be responsible, with the Principal Pharmacist, Head of Clinical Trials & R&D, for the operational management of the pharmacy clinical trials contract manufacturing service in line with the international ethical and scientific quality standard laid down in The International Conference on Harmonisation guidelines for Good Clinical Practice relating to trials (ICH GCP) and The EU Clinical trials directive (2001/20/EC) / UK SI 2012/1916 as transposed into UK law by the Medicines for Human Use (Clinical Trials) Regulations 2004 (the legislation), GMP Directive 2003/94/EC, and any other legislation or standards for the conduct of clinical trials. The post holder will manage a small but dedicated team for writing and implementing standard operating procedures for clinical trials and contract manufacture that will encompass the oversight of contract manufacture from financial negotiations, contract set-up, project management, distribution and liaising with the manufacturing teams.
About us
The Royal Free Hospital is a large teaching hospital situated in Hampstead, North London. We have one of the largest licensed production units in the UK and provide TPN, cytotoxic and CIVA services to the Trust and home care patients. We have an MIA(IMP) Licence and manufacture investigation medicinal products (IMPs) across the full range of products. This area of work is rapidly expanding. The pharmacy is progressive and friendly department offering a full range of services and education and training opportunities.
The post holder will be members of the pharmacy clinical trials manufacturing based team at the Royal Free London NHS Foundation trust. They will work with the team to ensure the smooth running of manufactured clinical trials handled by the Royal Free Pharmacy Clinical Trial Manufacturing and Supplies Team.
Job description
Job responsibilities
Your role is to manage our growing portfolio of projects and your time will be spent on assessing the feasibility of new projects, costing to ensure the unit runs at a profit, liaising with key staff in the production unit including procurement, manufacturing and quality control. You will ensure all projects are run efficiently and timelines are met. This will include discussion and liaison with doctors, nurses, clinical trials coordinators in the pharmaceutical industry or specialist companies and the production team at The Royal Free. You will provide expert trials manufacturing support to all departments. You will be integral in the development of the contract manufacturing team.
Job description
Job responsibilities
Your role is to manage our growing portfolio of projects and your time will be spent on assessing the feasibility of new projects, costing to ensure the unit runs at a profit, liaising with key staff in the production unit including procurement, manufacturing and quality control. You will ensure all projects are run efficiently and timelines are met. This will include discussion and liaison with doctors, nurses, clinical trials coordinators in the pharmaceutical industry or specialist companies and the production team at The Royal Free. You will provide expert trials manufacturing support to all departments. You will be integral in the development of the contract manufacturing team.
Person Specification
Royal Free World Class Values
Essential
- Demonstrable ability to meet the Trust Values
Education & professional Qualifications
Essential
- NVQ Pharmacy Services Level 3 plus an accredited underpinning knowledge or BTech Pharmaceutical Science or a pharmaceutical based degree which included clinical research as a subject
- Registered, or eligible to be registered, with Royal Pharmaceutical Society, if a pharmacy technician
Experience
Essential
- Significant experience of working in a hospital pharmacy or an industrial pharmaceutical clinical trials department
- Experience of supervising staff and workload on a day to day basis
- Portfolio demonstrating competence of previous and current pharmacy practice skills, knowledge and CPD
- Experience of writing Standard Operating Procedures
- Experience of preparing and organising clinical trials
Skills and aptitudes
Essential
- Knowledge of principles of GMP, GCP and Health and Safety
- Knowledge of principles of IMP and the EU Directive on Clinical Trials and their application in a practical situation
- Ability to make a wide range of Non-sterile, Sterile and Aseptic products
- Ability to work as part of and lead a team
- Ability to work alone and manage his / her own time
- Ability to train and assess others
- Ability to prioritise and organise routine daily tasks and non-routine tasks using own initiative
- Demonstrated pharmacy computer and IT skills, including data entry, word processing, email and internet
- Demonstrated ability to communicate more complex information effectively using clear written and spoken English and overcome barriers to understanding
- Demonstrated accurate numeracy skills, without using a calculator
- Demonstrated ability to maintain quality standards
- Demonstrated ability to solve complex problems
- Demonstrated ability to work under pressure accurately
- Demonstrated ability to motivate self and others
Personal Qualities & attributes
Essential
- Ability to teach others on a one to one basis and to give educational talks to mixed groups of staff
- Demonstrated ability to work with complex equipment
Others
Essential
- Demonstrated ability to work to set procedures
- Demonstrated knowledge of aspects of a GMP and QA system
- Demonstrated ability to deliver and validate staff training
- Demonstrated ability to accurately follow written procedures under pressure
- Demonstrated ability to undertake preparation of medicines requiring fine and accurate motor skills and concentration
- Demonstrated ability to handle hazardous materials safely according to local standard operating procedures
- Demonstrated ability to manage load handling issues and ensure local Manual handling procedures are followed
- Willingness to work at weekends and Bank Holidays as necessary
Person Specification
Royal Free World Class Values
Essential
- Demonstrable ability to meet the Trust Values
Education & professional Qualifications
Essential
- NVQ Pharmacy Services Level 3 plus an accredited underpinning knowledge or BTech Pharmaceutical Science or a pharmaceutical based degree which included clinical research as a subject
- Registered, or eligible to be registered, with Royal Pharmaceutical Society, if a pharmacy technician
Experience
Essential
- Significant experience of working in a hospital pharmacy or an industrial pharmaceutical clinical trials department
- Experience of supervising staff and workload on a day to day basis
- Portfolio demonstrating competence of previous and current pharmacy practice skills, knowledge and CPD
- Experience of writing Standard Operating Procedures
- Experience of preparing and organising clinical trials
Skills and aptitudes
Essential
- Knowledge of principles of GMP, GCP and Health and Safety
- Knowledge of principles of IMP and the EU Directive on Clinical Trials and their application in a practical situation
- Ability to make a wide range of Non-sterile, Sterile and Aseptic products
- Ability to work as part of and lead a team
- Ability to work alone and manage his / her own time
- Ability to train and assess others
- Ability to prioritise and organise routine daily tasks and non-routine tasks using own initiative
- Demonstrated pharmacy computer and IT skills, including data entry, word processing, email and internet
- Demonstrated ability to communicate more complex information effectively using clear written and spoken English and overcome barriers to understanding
- Demonstrated accurate numeracy skills, without using a calculator
- Demonstrated ability to maintain quality standards
- Demonstrated ability to solve complex problems
- Demonstrated ability to work under pressure accurately
- Demonstrated ability to motivate self and others
Personal Qualities & attributes
Essential
- Ability to teach others on a one to one basis and to give educational talks to mixed groups of staff
- Demonstrated ability to work with complex equipment
Others
Essential
- Demonstrated ability to work to set procedures
- Demonstrated knowledge of aspects of a GMP and QA system
- Demonstrated ability to deliver and validate staff training
- Demonstrated ability to accurately follow written procedures under pressure
- Demonstrated ability to undertake preparation of medicines requiring fine and accurate motor skills and concentration
- Demonstrated ability to handle hazardous materials safely according to local standard operating procedures
- Demonstrated ability to manage load handling issues and ensure local Manual handling procedures are followed
- Willingness to work at weekends and Bank Holidays as necessary
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).
