Band 6 Lead Project Manager, Clinical Trial Manufacturing & Supplies

at  Royal Free London NHS Foundation Trust

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.
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.
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.
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

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