Third Party Lab Contract Information Manager
AstraZeneca AB / Kemistjobb / Göteborg
2022-05-31
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hela Sverige 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.
What you'll do
As the Third Party Lab (TPL) Contract Information Manager you are responsible for Third Party Lab (TPL) human biological sample (HBS) operational contracting activities within a project. You are responsible for setting up and coordinating all TPLs contracted by AZ Translational Medicine and Translational Science for analysis using HBS for exploratory testing.
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Ensure AZ contracted analysis using HBS is high quality, compliant and delivers the scientific and operational needs of the project
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TPL Scope of Work (SOW) development, operational management of the contracted work, PO tracking, data transfers and risk and issue management
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Build and maintain relevant documentation e.g. vendor communication and escalation plan, vendor monitoring and QC plan, including eTMF upload.
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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.
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Ongoing operational monitoring of TPL during lifecycle of contract through to closure, including contract amendments
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Operational tracking of centrally located HBS via Global Code and other central tools
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Regular reporting of operational contracted activities to key partners
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Oversight of TPL data transfers and query resolution
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Work closely with Quality Assurance (QA) and Procurement as they handle QA Operational Due Diligence and Procurement activities related to TPLs.
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Can be assigned to specific tasks across Biosamples as required
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Chip in to the development of new processes and deployment of automation technologies where required
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Developing, maintaining and applying ongoing knowledge and awareness in trends, best practices and innovation in laboratory information management and country regulations
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Ensure compliance of the assigned activities with GCP, HGR and other country specific regulations
Minimum Qualifications:
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Experience with leading and negotiating Research and Development specific contracts.
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Degree (or relevant equivalent qualification) in relevant area, or relevant equivalent industry experience.
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Proficient in English as the AstraZeneca working language
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A clear demonstration of behaviours of
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Truth seeking rather than success seeking
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Agile responsiveness to scientific data
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Accepting of peer review
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Problem solver
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Demonstration of the AZ values
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Customer management
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Project management
Desired Qualifications:
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Clinical Laboratory scientific experience
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Experience in more than one company or country
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Confirmed experience in contributing to operational deployment of clinical laboratory testing
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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! Please apply as soon as possible but no later than 14 June, 2022.
Where can I find out more?
Follow AstraZeneca on LinkedIn
https://www.linkedin.com/company/1603/ Follow AstraZeneca on Facebook
https://www.facebook.com/astrazenecacareers/ Follow AstraZeneca on Instagram
https://www.instagram.com/astrazeneca_careers/?hl=enVaraktighet, arbetstid
Heltid Permanent
Publiceringsdatum2022-05-31ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2022-06-14
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-139718".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 6700797
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