Clinical Biomarker Operations Lead

EXCELYA; Paris; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

Excelya is seeking a Clinical Biomarker Operations Manager to lead biomarker activities across clinical development. You will oversee biospecimen management, external laboratories, and vendor oversight, delivering biomarker objectives from study start-up through close-out.

You will coordinate with Clinical Operations, Data Management, CROs and study teams, manage budgets and contracting for biobanking and biomarker vendors, and maintain GxP-compliant documentation and inspection readiness.

Formación

• Master's degree in Life Sciences or equivalent.
• Experience supporting biomarker operations within clinical development.
• Experience managing biomarker vendors, labs, or external providers.
• Experience coordinating biospecimen management and biobanking.
• Strong understanding of biomarker operations in clinical trials.
• Experience developing laboratory manuals and operation procedures.
• Knowledge of GxP requirements, inspections readiness, and clinical trial processes.
• Proficiency with MS Office, especially Excel.
• Experience with R or Python is a plus.
• Fluent English written and spoken.

Responsabilidades

• Lead biomarker operational activities across assigned clinical studies from start-up through close-out.
• Implement biomarker plans within study documentation and biobanking plans.
• Coordinate and oversee biomarker vendors, testing labs, and long-term biobanking providers.
• Ensure collection, processing, tracking, logistics, reconciliation of biomarker samples.
• Review biomarker deliverables, data tables, listings, and sample deviations.
• Monitor timelines, risks, quality metrics, and escalation activities.
• Maintain inspection readiness through eTMF management and GxP compliance.
• Coordinate biomarker activities with Clinical Operations, Data Management, CROs, and study teams.
• Manage budgets and contracting related to biobanking and biomarker vendors.

Conocimientos

Biomarker operations

Clinical biomarker programs

Vendor management

Biospecimen management

GxP knowledge

Cross-functional collaboration

Excel

English proficiency

Study start-up to close-out

Educación

Master's degree in Life Sciences

Herramientas

R

Python

Descripción del empleo

Excelya is seeking a Clinical Biomarker Operations Manager to lead biomarker activities across clinical development. You will oversee biospecimen management, external laboratories, and vendor oversight, delivering biomarker objectives from study start-up through close-out.

You will coordinate with Clinical Operations, Data Management, CROs and study teams, manage budgets and contracting for biobanking and biomarker vendors, and maintain GxP-compliant documentation and inspection readiness.