Biomarker Technical Expert (m/f/d)

Contract duration: 5 months

Responsibilities:

• Collaborate closely with TSL, Clinical Operations, Biostatistics/Bioinformatics, and data management teams to support and execute translational science strategies in clinical trials.
• Develop and provide operational input into all study related documentation and processes, and ensure collection, delivery and analysis of biomarker samples in compliance with these documents as well as GCP/ICH.
• Serve as a single point of contact for biomarker operations across functions, and with collaborators and CROs.
• Provide biomarker operational expertise and guidance to the study teams and ensure learnings are taken across teams (studies, programs); identify areas of best practice and process improvements.
• Work with data management for set-up and application of biomarker-relevant pages, coordination of biomarker data format and delivery timelines, data transfer specification setup, to ensure timely and efficient data delivery (data transfers, reconciliation, analysis, reports), mutual data transfers with Companion Diagnostics (CDx) partners for CDx regulatory submissions, if needed.

Requirements:

• Bachelor’s or Master’s degree in life sciences, molecular biology, biochemistry, or related field (PhD a plus).
• 5+ years of experience in clinical research, translational medicine, or biomarker operations within the pharmaceutical or biotech industry.
• Strong understanding of GCP/ICH guidelines, clinical trial processes, and sample/data management workflows.
• Demonstrated experience managing biomarker or laboratory activities within global clinical trials