Translational Medicine Senior Sample Operations Specialist
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.
Typical accountabilities
Provide critical support to oncology clinical trials by coordinating and tracking human biological sample (HBS) delivery for biomarker analysis at internal Cambridge Oncology Translational Medicine laboratories and external partners.
The role 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.
Main Accountabilities
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.
Providing hands-on support for HBS within Translational Medicine Cambridge laboratories – working with LIMS to accession samples into the lab, and collating sample sets for return to biobank or onward shipment.
Identifying lists of required samples from central laboratory/biobank/clinical inventories (monitoring sample accrual at appropriate intervals)
Coordinate approval of sample shipments following internal 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 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.
Essential Skills
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).
Desirable Skills
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).
Location: Cambridge UK
Why AstraZeneca?
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next?
If you are already imagining yourself joining our team, good, because we can’t wait to hear from you!
Competitive salary and benefits package on offer.
The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.
Date Posted
17-Mar-2023Closing Date
24-Mar-2023AstraZeneca 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.