Biomarker Clinical Operations Lead (m/f/d)
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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Facts about the job
Field
Other
Country
Switzerland
Location
Basel-Stadt
Contract type
Contracting
Job-ID
9S4DM3&origin=51001
Company
Coopers Group AG