Clinical Biomarker Operations Lead

Excelya Group; Paris (TX); On-site; USD 110,000 - 150,000; Full time

Job summary

Excelya is seeking a Clinical Biomarker Operations Manager to drive biomarker delivery across clinical studies. You will lead operational biomarker plan implementation, biospecimen management, and oversight of labs and vendors to ensure study milestones are met.

You will collaborate with Clinical Operations, Data Management, CROs, and cross-functional teams, maintain inspection readiness, and manage budgets for biobanking and biomarker services while adhering to GxP and quality standards.

Qualifications

• Master's degree or equivalent in Life Sciences.
• Experience supporting biomarker operational activities in clinical development.
• Experience managing biomarker vendors, testing labs, 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 Excel.
• Experience with R or Python is a plus.
• Fluent English (written and spoken).

Responsibilities

• 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.

Skills

Biomarker operations

Vendor management

Biospecimen management

GxP knowledge

Excel

R/Python

Fluent English

Education

Master's degree in Life Sciences

Job description

Excelya is seeking a Clinical Biomarker Operations Manager to drive biomarker delivery across clinical studies. You will lead operational biomarker plan implementation, biospecimen management, and oversight of labs and vendors to ensure study milestones are met.

You will collaborate with Clinical Operations, Data Management, CROs, and cross-functional teams, maintain inspection readiness, and manage budgets for biobanking and biomarker services while adhering to GxP and quality standards.