Clinical Trials Specialist

3 weeks ago

London, United Kingdom Guy's and St Thomas' NHS Foundation Trust Full time

The Pharmacy Manufacturing Unit (PMU) at Guy's Hospital is looking for self motivated and proactive individual with Clinical Trial experience to join our production team and support the delivery and maintenance of our Investigational Medicinal Product (IMP) manufacture service.

To be responsible for supporting the delivery of the PMU Clinical Trials service within the GMP and GCP legislative framework.

To provide expert input into all aspects of the Clinical Trial process from liaising with Sponsors, set up and manufacture of IMP, coordinating IMP supply and eventual closure and archiving of the trial

To be responsible for ensuring the requirements of the production area’s quality management system are maintained and developed as required by the MS(specials), MIA(IMP) licenses and NHS guidance.

To deputise for the Senior Production Pharmacist - Clinical Trials in their absence.

To act as a professional and technical role model for clinical trials within the Production Unit

The Pharmacy Manufacturing Unit (PMU) at Guy's Hospital is an MHRA licensed unit, manufacturing a broad portfolio of Specials (unlicensed) medicines and extemporaneously prepared products. These include non-sterile oral liquids & suspensions, tablets, capsules, creams & ointments and terminally sterilized parenteral solutions, topical gels and eye drops. Additionally, under our MIA(IMP) License, the PMU provides clinical trial manufacturing activities through our collaboration with Kings Health Partners and other clinical trial organizations.

Please see Job description for full details

Service Delivery

To coordinate with the Senior Operational Lead regarding preparation of Clinical Trial medicines to ensure a safe and efficient service.
To ensure that all IMP activities undertaken within the Production Unit comply with GMP/GDP/GCP, Health and Safety and COSHH legislation and that all work documentation and procedure manuals meet these regulations.
To support senior staff in the day-to-day management of clinical trials staff and workload in the allocated preparation area.
To ensure that all staff working on Clinical Trials in Production are trained and competency assessed in the tasks they undertake.

Clinical trials

To lead on the set-up and implementation of Clinical Trials requiring preparation or manufacture to ensure GMP, GCP, full protocol, CTA, and IMPD 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 supervise trainee pharmacists, STP students and trainee Production technicians when rotating through Production Clinical Trials.
To ensure effective communication is maintained with clinical trial sponsors and/or contract partners for any aspect of the Production Clinical Trial service delivery.
To be responsible for ensuring all Clinical Trial Site Master Files are updated and maintained contemporaneously in accordance with data integrity principles to be audit ready at all times.

Governance and Quality

To ensure that the Clinical Trial P harmaceutical Q uality M anagement system is maintained and developed in accordance with the MS(Specials) and MIA(IMP) license requirements and in response to changes in regulations and legislation.
To undertake a regular review of all quality exceptions according to department procedures.
To author and review deviation reports and change controls along with other PQS documents and assist in risk-based decision making on product quality and final product disposition from a production perspective in liaison with QA and the QP.
To support and document change through the Quality Management System to both reduce risk and drive innovation in clinical trial activities and the overall clinical trials service.
To ensure all changes to the Quality Management System are effectively communicated via the change control process to all grades of staff. By example and effective communication to create an environment of quality improvement.
To review and develop Standard Operating Procedures to ensure compliance with current and future clinical trial, manufacturing and regulatory requirements.
To participate in sponsor or other customer related audits for c

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