AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.
Come and join our AZ team where you will play a pivotal role in this exciting period of development!
Human Biological Samples (HBS) are fundamental to medical research in the discovery, development and implementation of new treatments and diagnostics. They are ethically critical materials and underpin the delivery of every clinical trial.
The Third Party Lab (TPL) Contract Information Manager role is responsible for Third Party Lab (TPL) human biological sample (HBS) operational contracting activities within a project. They are responsible for setting up and coordinating all TPLs contracted by AZ Translational Medicine and Translational Science for analysis using HBS for exploratory testing.
Ensure AZ contracted analysis using HBS is high quality, compliant and delivers the scientific and operational needs of the project
TPL Scope of Work (SOW) development, operational management of the contracted work, PO tracking, data transfers and risk and issue management
Build and maintain relevant documentation e.g. vendor communication and escalation plan, vendor monitoring and QC plan, including eTMF upload.
Contribute to study specific documentation such as Clinical Study Protocol, central lab SOW, Sample Lifecycle plan, eCRF, data transfer specification or agreement and risk log.
Ongoing operational monitoring of TPL during lifecycle of contract through to closure, including contract amendments
Operational tracking of centrally located HBS via Global Code and other central tools
Regular reporting of operational contracted activities to key partners
Oversight of TPL data transfers and query resolution
Work closely with Quality Assurance (QA) and Procurement as they handle QA Operational Due Diligence and Procurement activities related to TPLs.
Can be assigned to specific tasks across Biosamples as required
Chip in to the development of new processes and deployment of automation technologies where required
Developing, maintaining and applying ongoing knowledge and awareness in trends, best practices and innovation in laboratory information management and country regulations
Ensure compliance of the assigned activities with GCP, HGR and other country specific regulations
Experience with leading and negotiating Research and Development specific contracts.
Degree (or relevant equivalent qualification) in relevant area, or relevant equivalent industry experience.
Proficient in English as the AstraZeneca working language
A clear demonstration of behaviours of
Truth seeking rather than success seeking
Agile responsiveness to scientific data
Accepting of peer review
Demonstration of the AZ values
Clinical Laboratory scientific experience
Experience in more than one company or country
Confirmed experience in contributing to operational deployment of clinical laboratory testing
Validated experience in oversight of external partners, especially clinical laboratory service providers
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and ignite 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:
Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you!
Competitive salary and benefits package on offer.
Where can I find out more?
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