Biomarker Clinical Operations Lead

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