About the team

Translational Medicine supports programs in all phases of drug development and focuses on making measurements on human samples to understand why, and identify which, patients benefit from particular treatments, what doses and schedules of treatments to use and the mechanisms underlying the development of resistance to treatment.

In oncology studies, Translational Medicine are responsible for the biomarker strategy and implementation which includes delivering biomarker analyses of global oncology clinical trial samples.

The role holder will make an essential contribution to development of new cancer drugs, working with multifunctional global teams to manage the human biological samples.

Main Accountabilities

Provide critical support to multiple global oncology clinical trials by coordinating and tracking human biological sample (HBS) delivery for biomarker analysis at internal Oncology Translational Medicine laboratories and external partner labs.

The role holder will work closely with the Translational Medicine (TM) Leads, TM Laboratories, TM Operations Group, TM Quality Management, clinical study teams, Biosamples group including HBS Compliance & Governance, and external Laboratories. Effective delivery will require coordinated cross-functional project management.

• Clinical study-level sample management support, for translational endpoints in oncology trials.
• Enabling delivery of the right samples from the right patients, to the laboratory at the right time.
• Identifying lists of required samples from central laboratory/biobank/clinical inventories (monitoring sample accrual at appropriate intervals)
• Coordinate approval of sample shipments following AZ HBS Compliance & Governance processes for confirmation of consent and authorisation for use.
• Pro-actively requesting HBS shipment from the initial location, collating sample manifests with all required information, organizing shipment to the lab, tracking the samples and driving resolution of any issues.
• Reconcile shipments, identify and resolve discrepancies in sample information between AZ, central lab, biobank, and clinical sites.
• Proactively communicate updates and timelines to stakeholders.
• Provide advice and guidance to others on TM HBS processes
• Work with AZ HBS Compliance & Governance to oversee progress on submitted approvals and to prioritise them
• Collaborate with laboratory, operations and Quality Management personnel to develop improvements in implementation of sample management
• Ensure own work is compliant with Good Clinical Practice (GCP) and Human Tissue Act (HTA) regulations, AZ Policy on Human Biological Samples, Safety Health and Environment (SHE) standards and all other relevant internal AstraZeneca standards and policies.

Essentials for the role

• Bachelor’s degree or equivalent in a relevant field (e.g. biology, biochemistry).
• Relevant experience in the biopharmaceutical industry or clinical environment
• Must be meticulous and highly organised, with a keen eye for detail and accuracy in literacy and numeracy, to support preparation and review of documentation and spreadsheets.
• Can successfully multi-task, supporting multiple projects simultaneously.
• Hands-on experience managing HBS in a biorepository and/or biospecimen department or on clinical trials
• Excellent working knowledge of Excel.
• Familiarity with LIMS or other complex database/inventory systems
• Ability to coordinate cross-functional activities and advise colleagues on process and procedure
• Ability to work effectively with colleagues/collaborators from a diverse set of backgrounds, levels of seniority, and territories.
• Strong communication skills, ability to deliver to specified timelines and provide updates proactively in a fast-paced changing environment.
• Flexibility and willingness to adapt as the requirements of the role changes.
• Ability to identify risks and have the confidence to escalate appropriately.

Desirables for the role

• Experience with relevant oncology clinical specimens (e.g. formalin fixed tissues, blood or blood products).
• Experience in contributing to operational deployment of clinical laboratory testing
• Conducting work to Good Clinical Practice (GCP) and/or within a regulatory /quality framework (e.g. ISO 15189-, CAP-, CLIA-accredited lab environment).
• Competency in advanced excel functions including pivot tables, VLookup.

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.