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Biomarker Lead F/H - Boulogne-Billancourt, France - Excelya
Description
Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey. For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
For the clinical trials that will be assigned:
• Establish clinical biomarker plans that support clinical development plan and that are suitable for informed decision making
• Implement the clinical biomarker plans into clinical study documentation (e.g. protocol, laboratory manual, ICF) in collaboration with clinical operation teams.
• Provide input to the study feasibility requirements (related to biomarker sample collection, management and logistics), to the service provider regarding biomarker sample and data requirements
• Identify, select, qualify and monitor vendors for biomarker validation and analysis to ensure compliance and high quality data
• Coordinate biomarker data collection, biomarker data analysis, review and interpretation
• Work closely with clinical operation and data management teams and CROs, to monitor ongoing biomarker activities:
• Monitor appropriate collection, processing, tracking, logistics and analysis as defined in laboratory manuals, sample flows and sample management plans
• Write and implement Biomarker/Biobanking Sample Management Plans
• Perform reconciliation of biomarker samples to ensure that samples were collected according to protocol, ICF and laboratory manual
• Follow up with Central Laboratories and biomarker vendors on issues/deviations regarding biomarker samples and data. Ensure that adequate actions are implemented for samples/data collected in deviation.
Key Competencies
• Deep understanding of clinical biomarkers in drug development
• Demonstrated experience in the appropriate application of various scientific technologies into biomarker strategies
• Demonstrated scientific acumen and mechanistic understanding of disease biology
• Good analytical and problem-solving skills
• Demonstrated experience in clinical sample management
• Good experience with Office tools (Excel)
• Strong familiarity with GCP
• Good experience working with CROs, clinical operations, data management
• Fluent in English
