Clinical Biomarker Manager

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

We are looking for a Clinical Biomarker Operations Manager to support biomarker activities across clinical development programs. In this role, you will lead the operational implementation of biomarker plans, oversee biospecimen management activities, manage external laboratories and vendors, and ensure the successful delivery of biomarker objectives from study start-up through study close-out.

• →Lead biomarker operational activities across assigned clinical studies from start-up through close-out.
• →Implement biomarker plans within study documentation, including laboratory manuals, informed consent forms (ICF), sample management plans, and biobanking plans.
• →Coordinate and oversee biomarker vendors, testing laboratories, and long-term biobanking providers.
• →Ensure appropriate collection, processing, tracking, logistics, reconciliation, and long-term management of biomarker samples throughout the study lifecycle.
• →Review biomarker operational deliverables, data tables, listings, and sample-related deviations.
• →Monitor timelines, risks, quality metrics, and escalation activities to ensure successful biomarker delivery.
• →Maintain inspection readiness through appropriate documentation, eTMF management, and compliance with applicable GxP requirements.
• →Coordinate biomarker activities with Clinical Operations, Data Management, CROs, and cross-functional study teams.
• →Manage budgets and contracting activities related to biobanking and biomarker vendors.

• Master's degree or equivalent in Life Sciences.
• Experience supporting biomarker operational activities within clinical development programs.
• Experience managing biomarker vendors, testing laboratories, or external service providers.
• Experience coordinating biospecimen management, sample logistics, reconciliation, and biobanking activities.
• Strong understanding of biomarker operations within clinical trials.
• Experience developing laboratory manuals, sample management plans, assay documentation, and operational procedures.
• Good understanding of GxP requirements, quality standards, inspection readiness, and clinical trial processes.
• Proficiency with Microsoft Office, especially Excel.
• Experience with R or Python is a plus.
• Fluent English (written and spoken).