Biomarker Clinical Operations Lead
m/f/d, Basel-Stadt
The Biomarker Clinical Operations Lead is responsible and accountable to provide BIOMARKER OPERATIONAL EXPERTISE by planning, coordinating, and overseeing all operational activities for the lifecycle of biomarker and companion diagnostic samples and data, for clinical studies.
Duration: 12 months/will be extended
Location: Basel
Workload: preferably 100%
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
* Provide technical knowledge of aspects related to biomarker analyses (e.g. sample collection and handling, assay, device and imaging technologies)
* 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
* Provide responses to biomarker sample/IVD related questions or issues from Health Authorities
Requirements:
* Minimum Bachelor/Master in Life Sciences (in Scientific, Medical or Healthcare subject area)
* 3+ years of experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
* Extensive clinical development experience with evidence of working in teams running clinical studies
* Strong experience with vendor and project management
* Possess strong knowledge of drug development process and respective regulations, including ICH and GCP guidelines
* Have a clinical or laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
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