Specialist, Clinical Supply Chain

Job Title

Specialist, Clinical Supply Chain

Immunocore

Gaithersburg, MD;
Radnor, PA;
Oxford, UK

Clinical Supply Chain

The Specialist, Clinical Supply Chain role will maintain drug manufacturing and clinical supply chain record keeping in either the Trial Master File or sponsor files in accordance with regulatory expectations. It helps to ensure effective management of drug manufacturing and the supply chain, ensuring seamless provision of drug and ancillary supplies across the clinical portfolio. The Specialist will work closely with internal clinical supply chains, clinical operations, regulatory and manufacturing colleagues to assist in the delivery of clinical supplies in line with related regulatory requirements and internal quality processes.

• Continuously and proactively gather and file clinical supplies related paperwork into either the Trial Master File or sponsor files, ensuring records are inspection ready and compliant with regulations.
• Collaborate with Clinical Supplies Managers in setting up supply chain strategies for clinical studies, resolving issues, sharing best practice, and continually developing competence.
• Design and implement labelling, packaging and supply strategies that meet study design, site, and regulatory requirements while maximizing efficiency.
• Contribute to clinical supply agreement documents, documenting the agreed supply option and detailing the design, setup and operation for responsible studies.
• Manage labelling, packaging and distribution activities, including review and approval of labelling/packaging records and distribution plans.
• Help ensure seamless provision of drug and ancillary supplies by carrying out activities such as:
  • Management of drug temperature excursions during shipment and storage.
  • Drug usage forecasting.
  • Contributing to the design and testing of IRT systems during study setup.
  • Administration and monitoring of IRT systems for drug supply demands.
  • Arranging and monitoring depot and site shipments as required.
  • Troubleshooting site clinical pharmacy issues.
• Assist with activities to help monitor individual study budgets including recording in invoice trackers.
• Support preparing, reviewing, and formatting support documents for clinical trials, including pharmacy handling instructions, pharmacy manual, distribution project specifications, etc.
• Contribute to and review SOPs related to Clinical Supplies and Manufacturing required for the Quality Management system.
• When required, contribute to and review documents for submissions to regulators or ethics committees.
• Assist with the preparation of documentation associated with the assessment, evaluation, and management of CMOs, distribution depots, and other contractors involved with clinical trial supplies.
• Provide pharmacy training to clinical trial personnel as necessary, which may involve traveling nationally and internationally for face-to-face training.
• Initiate Quality Events where appropriate and support investigation and root cause analysis, including execution of associated CAPAs.

• Worked within pharmaceutical quality systems, with a sound understanding of principles of “good practice”.
• Worked within the drug development industry.
• Worked collaboratively with other internal teams.
• Worked to foster support and influenced all study stakeholders throughout the life of a project.
• Worked to meet deadlines.
• Worked to an exceptional standard regarding organisational and computer skills (Word, Excel, Power point, Outlook).

• Worked in early phase clinical trials.
• Knowledge and experience in Oncology therapeutic discipline.
• Proven track record of successfully contributing to the running of clinical study projects in a pharmaceutical/biotech business environment.
• Worked in GMP or clinical supplies.
• Knowledge of the Industry/Clinical trial process and drug development.
• Knowledge of ICH GCP.
• Knowledge of GDP.
• Knowledge of the Clinical Trial Directive and global regulatory environment regarding investigational products.

• Communication proficiency in local language.
• Must work with professional discretion and confidentiality.
• High…