David P. Swieboda
Third Party Lab (Tpl) Information Manager @阿斯利康
Signup · Get unlimited contacts
WORK HISTORY
Third Party Lab (Tpl) Information Manager @阿斯利康
As a the Third Party Lab (TPL) Contract Information Manager, my role is responsible for Third Party Lab (TPL) human biological sample (HBS) operational contracting activities within a project. I am responsible for setting up and coordinating all TPLs contracted by AZ Translational Medicine and Translational Science for analysis using HBS for exploratory testing. My main duties-Ensuring 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 -Building and maintaining relevant documentation e.g. vendor communication and escalation plan, vendor monitoring and QC plan, including eTMF upload-Contributing 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-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 regulation
EDUCATION
West London College
IELTS, FCE, CPE, English as a foreign language
Imperial College London
MRes, Biosciences
Imperial College London
Doctor of Philosophy (PhD), Medicine
Uniwersytet Marii Curie-Skłodowskiej w Lublinie
MSc, Biotechnology, Virology, Immunology
ABOUT DAVID P. SWIEBODA
Passionate and results-oriented professional with extensive experience managing…
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.