Freelance Consultant for Lab Management (f/m/d)

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Remote |

Freelance

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:

Reference number: 14364

Industry: Biotech

Project start: ASAP

Duration: 6 Monate

Employment type: Freelance

Contact

Milena Heidinger

ADESW