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Clinical Trials Specialist
2 weeks ago
Due to promotion we have a vacancy in our clinical trials team based in the pharmacy manufacturing unit at Guys.
We are looking for an individual with experience in working in a clinical trials capacity this may be as a CRO, for a sponsor, manufacturing unit or other relevant role to join our team.
The role provides leadership and oversight of the clinical trials service in the manufacturing unit including liaison with other departments, sponsors and quotations for example.
**General**:
4.1 To coordinate with the various manufacturing teams regarding preparation of Clinical Trial medicines to ensure a safe and efficient service for Trust and external patients. The post holder will work primarily in the Pharmacy Manufacturing Unit at Guy’s Hospital but may on occasions be required to attend external sites for specific duties.
4.2 To ensure that all activities undertaken within the units meet current legislation such as GMP/GDP/GCP, Health and Safety, COSHH, as well as professional requirements and that all work documentation and procedure manuals meet these regulations.
4.3. To support senior staff in the day-to-day management of clinical trials staff and workload in the allocated preparation area.
4.4 To deputise for the Senior Pharmacist(s) responsible for Clinical Trials in their absence.
4.5 To act as a professional and technical role model for clinical trials within the pharmacy production unit clinical trials team and wider production department.
- Undertake - where required - preparation of any products following adequate training or supervision of the manufacturing process for clinical trials including physiological studies.
- To undertake the final production check as an authorised production product checker of clinical trials and batch manufactured products prepared under the MS and MIA(IMP) licences and extemporaneous products (where qualified to do so).
Based in the Guys Pharmacy Manufacturing unit you will be part of an overall team of 120 staff across the trust working.
The clinical trials team consists of 3 key staff members who are interlinked with the different manufacturing and quality teams.
The technical services department at Guy’s and St Thomas NHS Foundation Trust is a large department comprising of aseptic, sterile and non-sterile manufacturing with full support from on-site Quality Control and Quality Assurance teams. There is a classical manufacturing facility and an Aseptics unit on the Guy’s site, a Parenteral Nutrition Unit on the St Thomas site and a chemotherapy manufacturing unit within the Cancer Centre also located on the Guys Hospital Site.
Each unit has a full complement of Pharmacists, Technicians and Assistants and prepare a wide range of products under several MHRA issued licences.
Clinical Trials / Research and Development
- To lead on the set-up and implementation of Clinical Trials requiring preparation or manufacture to ensure full protocol, CTA, IMPD along with GMP and GCP compliance.
- To generate quality technical agreements, commercial and supply agreements in response to acceptance of a clinical trial, liaising regularly with the trial sponsor.
- To generate or contribute to the continued maintenance of trial specific IMPD’s in liaison with the local site QA, QP, QC department and trial sponsor.
- To lead on generation of batch specific documentation such as training logs, batch manufacturing records and any other required trial specific documentation.
- To supervise the clinical trials co-ordinator and clinical trials workload on a day to day basis and report regularly on the status of clinical trials to the production manager highlighting any resource requirements.
- To oversee the manufacture of clinical trials and training on trial specific protocols and manufacturing methods to ensure other staff are aware of the trial-specific requirements of the batch/product.
- To ensure the security and confidentiality of trial product specification and pharmacy held trial files are maintained at all times.
- To liaise closely with the product development and lifecycle team on any requirements for new formulation development or where work up is needed for placebo matched or comparator studies to ensure blinding can be maintained (where applicable).
- To represent the clinical trials team at the product development meetings raising any items which need to be reviewed and discussed by the group to aid trial activity to meet given timelines.
- To supervise undergraduate students and pre-registration pharmacists rotating through the department.
- To assist the section manager in developing all aspects of the trials manufacturing service in accordance with jointly agreed objectives between the post holder and the Production Manager.
- To regularly liaise with suppliers of key trial related manufacturing equipment such as tablet tooling providers and draw up and approve technical drawings and specifications for such equipment including IOPQ documentation
