Biosampling Project Manager
Core
Lead and coordinate central laboratory activities for global clinical studies, managing human biological samples from study start-up to close-out.
Role type
Senior Project Manager (Clinical Laboratory Operations)
Builds
Central laboratory operations and sample management processes for clinical trials
Domain
Healthcare / Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Project management, Human Biological Sample Management (HBSM) planning, risk assessment, laboratory operations oversight, budget management, vendor management, cross-functional stakeholder coordination, ICH-GCP and GCLP knowledge
Preferred skills
Experience in global matrixed organizations, continuous improvement of laboratory processes
Technologies
None stated
Responsibilities
Serve as primary point of contact between study teams and central laboratory partners; coordinate management of human biological samples; develop and maintain HBSM Plans and Sample Risk Assessments; ensure appropriate sample flow and laboratory data delivery; oversee sample chain of custody and issue resolution; manage laboratory budgets and performance reporting; collaborate with Clinical Operations, Data Management, and vendors; drive continuous improvement of laboratory processes
Seniority
Senior, hands-on IC