Band 6 Lead Project Manager, Clinical Trial Manufacturing & Supplies

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Our trust has around 10,000 staff serving 1.6 million patients. It comprises Barnet Hospital, Chase Farm Hospital, the Royal Free Hospital and more than 30 services in the community. This larger scale organisation provides an unprecedented opportunity for us to continue our pioneering work, particularly in finding ways to deliver even better care to our patients.

Our mission is to deliver world class care and expertise in our clinical services, underpinned by world class teaching and research and we will continue to measure our progress against our five governing objectives: excellent outcomes, excellent patient and staff experience, excellent value for taxpayers' money, being safe and meeting our external duties, and building a strong organisation.

Everyone is welcome at Royal Free London NHS Foundation Trust. We're proud of our diversity and we continue to undertake new initiatives to advance equality for LGBT+, BME, gender equality, staff carers and people with disabilities and lived experiences to promote good relations and understanding between our staff.

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Job overview

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.

Working for our organisation

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.

Detailed job description and main 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 criteria

• Demonstrable ability to meet the Trust Values

Education & professional Qualifications

Essential criteria

• 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 criteria

• 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 criteria

• 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 criteria

• 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 criteria

• 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

• Covid-19 Vaccination

  Getting vaccinated, and getting a booster, remains the best defence against COVID-19.
  We encourage and support staff to get COVID-19 vaccine and a booster dose as and when they are eligible.

• AT* - Apprenticeship Training. Where AT* is entered next to the job title indicates that this vacancy is for an apprenticeship role.
• By applying for this role, you accept if successful, that your personal data may be transferred from the Trust to another NHS organisation where your employment transfers within the NHS. This is in accordance with the streamlining programme which aims at saving you time and improving efficiencies within the NHS when your employment transfers. Therefore we require you to complete your stat and Man e-learning modules prior to joining our organisation.
• If you are an EU/EEA citizen who does not have EU Settlement or Pre-Settled status, you will require a visa to work in the UK.
• Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. Before submitting your application and to avoid disappointment please check that you are eligible under the UKVI points based system.
• If you are offered a role with one of the NLPSS partner trusts, as part of pre-employment checks your identity and right to work documentation will be verified remotely (in most circumstances), using a certified identity verification service provider TrustID. You will be asked to capture an image of the relevant documents as well as a "selfie" using your smartphone/tablet (if available) for facial matching. TrustID will also perform a digital address check using Trunarrative and Equifax, which is a soft check and does not leave a footprint on your credit rating. For more information, visit www.trustid.co.uk
• The Trust uses electronic new starter forms on Trac to collect personal details. Information collected is securely stored and used to set up the employee record on the ESR HR system.
• The Trust will request a DBS (CRB) if post involves regulated activities. The Trust is compliant with the Disclosure and Barring Service Codes of practice and the Rehabilitation of offenders act.
• By applying for this post you are agreeing to Royal Free London NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job, information will also be transferred into the national NHS Electronic Staff Records system.
• Please be aware of scams - unless specified above, we will only communicate with you via @recruit.trac.jobs or nhs.net e-mails and we will never ask you for any payments.

Applications are welcome from people wishing to job share or work flexible patterns. We are committed to equal opportunities.

Please note:

• Due to the high number of applications that are received for some posts we may close this vacancy before the advertised closing date. Therefore please apply for this post as soon as you can, if you are interested and you meet the requirements of the Person Specification
• Only those candidates who clearly demonstrate how they meet the person specification will be shortlisted for this job.
• Interview arrangements will be communicated via email so please check your email regularly following the closing date.

Please be advised that due to exceptionally high demand, all Royal Free accommodation is at full capacity and waiting lists are being held. Average waiting times are 12 months. Please do not rely on Trust accommodation when you commence your role and ensure you investigate alternative accommodation for your arrival.

Employer certification / accreditation badges

Applicant requirements

You must have appropriate UK professional registration.

This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.

Documents to download

• Band 6 Lead Project Manager, Clinical Trial Manufacturing & Supplies (PDF, 236.1KB)
• Band 6 Lead Project Manager, Clinical Trial Manufacturing & Supplies (PDF, 146.5KB)
• Functional Requirements Form (PDF, 144.6KB)