What you’ll do

The Translational Medicine Genomics Lab leads analysis of clinical samples using the best available solutions to improve value for oncology projects. We deliver genomic biomarker assays for patient stratification/selection and to inform understanding of therapeutic response and resistance. We provide robust technology development and benchmarking capabilities, internal assay platforms as well as high quality assays from a network of external vendors. We also provide specialist genomics consultation to support cutting edge translational research and oncology drug portfolio support.

The role holder will support critical clinical sample operations needs for our UK Genomics Lab team with additional support activities for other UK lab groups where possible. You will work with multiple internal and external stakeholders to plan, execute, and troubleshoot sample logistics and related demands. Stakeholders will include: TM Labs scientists, TM Leads (Strategists), TM Operations, the AZ Biobank, Biosamples Project Leads (BPL), Covance/Lapcorp Clinical Sample Scientists (CSS), Global Study Managers/Associate Managers (GSM/GSAM), and others as required.

This role requires in-depth knowledge of the requirements and complexities of working with patient samples from clinical trials to deliver important biomarker data whilst ensuring full compliance with our legal and ethical obligations. The role may grow to provide expertise to global TM teams.

Core duties/activities will include:

• Provide advice to scientists regarding sample acquisition, sample data management and supply

• Sample tracking and shipments – create inventories and trackers/pick lists, locate and facilitate the movement of samples as needed

• Perform consent checks and ensure sample owner approval of planned work, prepare and file relevant documentation to ensure compliance

• Raise Biobank requests (via the AZ biobanking system) and perform related queries for clinical and commercial samples

• Arrange for movement of samples to support analyses at external and internal labs

• Resolve sample discrepancies (e.g. shipment vs manifest issues, 3rd party accession documentation)

• Arrange for repatriation of residual samples to the appropriate Biobank

• Provide expert user support in the use of BSI LIMS for sample tracking across the TM lab groups; Liaise with internal and external support to help resolve enquiries or issues. Provide hands-on support when needed

• Support related systems, e.g. labelling software/printers; Provide ad hoc training to staff as required

• Work closely with TM Lab teams to understand their needs and proactively identify areas for process improvement/simplification

• Prepare and update documentation / SOPs related to handling of clinical samples

• Ensure all sample related activities are undertaken in a fully compliant manner (e.g. AZ policy on Human Biological Samples, the UK Human Tissue Act, all ethical, consent, and data privacy requirements)

• Work with TM Genomics UK scientists to prepare for HBS/HTA audits and resolve any observations / actions resulting

• Dependent on experience, the role holder may be assigned as "Person Designate" for TM Darwin labs for the purposes of HTA compliance

Essential for the role

• Bachelor’s degree or equivalent in a relevant field (e.g. biology, biochemistry)

• Direct experience of managing the request and movement of clinical samples for biomarker analyses, including tracking of consent

• Must be meticulous and highly organised, with a keen eye for detail to support preparation and review of documentation

• Good understanding of GCP and the UK Human Tissue Act in relation to working with clinical samples

• Ability to work effectively with colleagues/collaborators from a diverse set of backgrounds, levels of seniority, and territories

• Experience managing a broad portfolio of work on multiple clinical studies simultaneously

• Experience of biobanking software/tools, and sample tracking LIMS such as BSI

Desirable for the role

• Experience in the biotech/pharmaceutical industry

• Experience with relevant oncology clinical specimens (e.g. formalin fixed tissues, blood or blood products)

• Conducting work to Good Clinical Practice (GCP) within a regulatory /quality framework (e.g. ISO 15189-, CAP-, CLIA-accredited lab environment)

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

• If you’re curious to know more then please reach out to Louise Bennett

Competitive salary package and benefits

Close Date: 17/09/2021

Where can I find out more?

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Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.