Translational Medicine Senior Sample Operations - Cambridge, United Kingdom - AstraZeneca

AstraZeneca

Verified Company

Cambridge, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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 studylevel 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 handson 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.
Proactively 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, CLIAaccredited 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, CLIAaccredited 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?