Senior Manager Biosample Operations Lead
Core
Own end-to-end biosample operations across assigned clinical studies, ensuring samples are collected, processed, analyzed, and stored to the highest quality and regulatory standard while managing vendor performance and team execution.
Role type
Senior Manager, Biosample Operations Lead
Builds
Clinical study biosample lifecycle management and data delivery
Domain
Healthcare intelligence, Clinical Research, Biobanking
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biosample lifecycle management, Vendor selection and qualification, Cross-functional team leadership, Risk and issue management, Budget planning and forecasting, Regulatory compliance (ICH-GCP, GCLP), Protocol and manual review, Audit and inspection readiness
Preferred skills
Biomarker and bioanalytical operational expertise, Process improvement initiatives, Subject matter expertise
Technologies
None explicitly stated
Responsibilities
Provide strategic input for operational feasibility and execution of biosample activities; Manage biosample activities for low to moderate complexity studies; Lead cross-functional team meetings to review status and mitigate risks; Act as single point of contact for Study Team on biosample aspects; Contribute to central lab vendor selection and qualification; Oversee central lab set-up and vendor performance; Manage CRO and central lab interfaces; Lead budget planning and forecasting; Ensure compliance with ICH-GCP, GCLP, and ethical standards; Lead audit and inspection readiness; Drive process improvements.
Seniority
Senior, hands-on IC with team leadership
