Archiviertes Projekt - Freelance Consultant for Lab Management (f/m/d)

Zu besetzendes Projekt: Freelance Consultant for Lab Management (f/m/d)
Branche: Biotech
Projektstart: ASAP
Projektdauer: 6 Monate mit Option auf Verlängerung
Auftragsvolumen: ca. 720h
Einsatzort: Remote

Aufgaben:
·Coordination/Management of all required labs in terms of processes, quality and cost oversight and control
·Overseeing supply of approx. 50 EU trial sites (sample collection, shipment & implementation)
·Ensuring results independently for an in-time submission of MAA
·Securing high data quality by steering scope of validation of assays (fit for purpose is lower quality and sometimes higher quality is needed)
·Creating processes for smooth logistics of samples (central labs) in coordination with internal stakeholders
·Identification of optimal solutions for sample labelling and for supplying laboratories/sites with sample collection kits for each individual CIT
·Lab vendor management: identifying possible lab vendors (qualification of lab vendor, subject matter expert contracts, budget negotiation)
·Independent development of expert file templates including lab manuals, training materials, labels (design, print as required)
·Set-up of assay validation at lab vendor (if new assay needs to be developed)
·External training of sites and laboratories with regards to sample handling, sample analysis (where applicable), logistics
·Overseeing harmonization of processes/manuals between clinical trials performed in ClinDev EU
·Generate, update and review SOPs where required
·Ensure availability of translations to local languages where needed e.g. for lab manuals for the sites or courier instructions.
·Advice on Management of Clinical Trial Lab Logistics

Qualifikationen:
·Englisch Must-have, Deutsch Nice-to-have
·Handling und Validierung von Laboren
·Regulatorische Erfahrung (MAA/BLA submission)
·Erfahren im klinischen Umfeld