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The Clinical Trials Laboratory Manager is a senior leadership role within the Human Biological Samples Management (HBSM) team at ICON. The successful candidate will have a strong background in clinical laboratory operations and experience working with central laboratory activities.
This role requires a strong understanding of laboratory processes and compliance with ICH-GCP/GCLP rules. You will work closely with the HBSM team to ensure the management of HBS and associated laboratory activities meet quality and regulatory standards.
Responsibilities:
- Lead the operational setup and follow-up of central laboratory activities for projects or groups of studies.
- Ensure effective interface between Central Laboratory (CL) and Clinical Study Project Management Team, Precision Medicines & Vaccines Clinical Laboratory & Assay Portfolio, and Human Genetics.
- Main point of contact for the clinical study team and Central Laboratory.
- Responsible for overview of Human Biological Samples Management in assigned projects, including support investigator sites and testing issues in Central Laboratory.
- Oversight of chain of custody of Human Biological Samples throughout the lifecycle of the study, including site-central lab and provide consultations for HBSM team.
- Follow up on study KPIs, identify trends, and ensure problems with HBSM are addressed.
- Act as Subject Matter Expert (SME) for one or several processes of the team.
- First point of Central Laboratory escalation for the clinical study teams, understand, mediate, and solve complex issues related to deliverables and escalate as required.
- Monitor study-related activities to provide management with consolidated information on central laboratory, sample management, data delivery, CL budget review & annual forecast, and key performance indicators to surface HBSM issues.
- Support external and internal project audits in CL/HBSM part.
- Support CL database reconciliation with all CL-related issues based on strong cooperation with assigned Data Manager.
We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development in a dynamic and supportive environment.
