Duration:12months/willbeextendedLocation:BaselWorkload:preferably100%ResponsibilitiesProvide biomarker/IVD operational expertise to clinical study teams to ensure operational feasibility and quality data deliveryBe accountable for the development of the BIOMARKER MANAGEMENT PLAN and the execution of deliverables for assigned drug and device studies (e.g. IVD clinical performance studies)Manage all study level biomarker operations activities for both clinical (i.e. drug) and IVD studies (e.g. manage vendor/testing sites, ICF/protocol input, eTMF/RACT set-up, sample/data flow, data quality and transfer set-up)Actively partner with Data Management to oversee and coordinate biomarker data formatCOLLABORATE AND PARTNER with cross functional stakeholders (e.g. study team members, procurement, testing site monitors, diagnostic partners, central lab) to execute biomarker/IVD operational strategies, serving as a single point of contact for biomarker/IVD operations on multiple study teamsProvidetechnicalknowledgeofaspectsrelatedtobiomarkeranalyses(e.g.samplecollectionandhandling,assay,deviceandimagingtechnologies)Develop and oversee biomarker analysis TIMELINES, BUDGET, RISK, COMPLIANCE and QUALITYAttend operations team meetings and investigator/monitor meetings, as applicable, to deliver presentations and in depth trainings to internal and external stakeholders on biomarker and companion diagnostic sample collection, handling and IVD proceduresProvideresponsestobiomarkersample/IVDrelatedquestionsorissuesfromHealthAuthoritiesRequirementsMinimum Bachelor/Master in Life Sciences (in Scientific, Medical or Healthcare subject area)3+yearsofexperienceinaclinicalresearchsetting,clinical/diagnosticlaboratory,orpharmaceutical/biotechnologyR&DenvironmentExtensive clinical development experience with evidence of working in teams running clinical studiesStrongexperiencewithvendorandprojectmanagementPossessstrongknowledgeofdrugdevelopmentprocessandrespectiveregulations,includingICHandGCPguidelinesHaveaclinicalorlaboratoryexperiencewithevidenceofinvolvementintheprocessingand/oranalysisofbiologicalsamples
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