Duration:12months/willbeextended
Location:Basel
Workload:preferably100%
Responsibilities
* Provide biomarker/IVD operational expertise to clinical study teams to ensure operational feasibility and quality data delivery
* Be 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 format
* COLLABORATE 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 teams
* Providetechnicalknowledgeofaspectsrelatedtobiomarkeranalyses(e.g.samplecollectionandhandling,assay,deviceandimagingtechnologies)
* Develop and oversee biomarker analysis TIMELINES, BUDGET, RISK, COMPLIANCE and QUALITY
* Attend 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 procedures
* Provideresponsestobiomarkersample/IVDrelatedquestionsorissuesfromHealthAuthorities
Requirements
* Minimum Bachelor/Master in Life Sciences (in Scientific, Medical or Healthcare subject area)
* 3+yearsofexperienceinaclinicalresearchsetting,clinical/diagnosticlaboratory,orpharmaceutical/biotechnologyR&Denvironment
* Extensive clinical development experience with evidence of working in teams running clinical studies
* Strongexperiencewithvendorandprojectmanagement
* Possessstrongknowledgeofdrugdevelopmentprocessandrespectiveregulations,includingICHandGCPguidelines
* Haveaclinicalorlaboratoryexperiencewithevidenceofinvolvementintheprocessingand/oranalysisofbiologicalsamples
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