Manager, Clinical Samples

Role Overview

• Develop and oversee global clinical sample management strategies for assigned Phase 1–3 trials
• Lead operational planning for all sample-related activities, including collection, processing, shipping, storage, chain-of-custody, and destruction
• Collaborate with Clinical Operations, Clinical Pharmacology/Bioanalysis, Data Management, and Regulatory Affairs to ensure sample plans align with protocol requirements and scientific objectives
• Collaborate with Outsourcing and Vendor Governance (OVG) for vendor selection and contracting
• Provide oversight of central labs and assigned specialty labs, couriers, and biorepositories
• Ensure laboratory manuals and sample handling instructions are complete, clear, and version-controlled
• Collaborate with central lab to oversee and monitor sample inventory and tracking systems, ensuring accuracy and regulatory compliance
• Establish and maintain internal metrics and KPIs for sample management performance; present regular updates to study teams
• Support sample-related sections of protocols, ICFs, and monitoring plans
• Drive resolution of sample-related issues, deviations, and CAPAs in collaboration with QA and vendors
• Collaborate with Data Management to resolve queries during reconciliation processes
• Maintain awareness of evolving global regulations and guidance for biological specimen handling, import/export, and privacy requirements
• Provide training and subject matter expertise to internal teams, CROs, and site staff
• Contribute to inspection readiness and participate in audits or regulatory inspections as the SME for sample management
• Travel as required to support site initiation, vendor audits, and troubleshooting

Requirements

• Bachelor’s degree in biological sciences or related discipline; advanced degree preferred
• 8+ years of relevant clinical trial sample management experience
• Demonstrated expertise in GCP, ICH guidelines, and global regulations related to biological specimens
• Proven success in vendor management and cross-functional collaboration
• Strong project management, problem-solving, and negotiation skills
• Experience with LIMS, sample tracking software, and EDC/CTMS systems preferred
• Exceptional organizational and communication skills, with the ability to influence and collaborate at all levels.

Tech Stack

• Google Cloud Platform

Benefits

• health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
• 20 days of PTO
• 10 paid holidays
• winter company shutdown
• discretionary annual target bonus
• stock options
• ESPP
• 401k match