Clinical Trial Sample Manager

Key Responsibilities

• Oversee clinical trial sample lifecycle: collection kit design, site training, sample receipt, accessioning, storage, retrieval, shipment, and final disposition/destruction.
• Reconcile sample inventory against clinical database (EDC) and protocol-specified visit/sample schedules.
• Cook with clinical sites, CROs, and central/specialty labs to resolve sample discrepancies, missing samples, or shipment issues.
• Manage cold chain logistics for domestic and international shipments (ambient, refrigerated, frozen, dry ice, LN2 vapor shippers), including customs/import-export documentation.
• Ensure chain-of-custody documentation supports GCP compliance and audit-readiness.
• Develop and maintain SOPs for sample handling, labeling, shipping, and biobank retention/destruction per protocol and informed consent terms.
• Support development of laboratory manuals and sample collection kits for clinical trial protocols.
• Track sample retention and future use consent (e.g., for genomic/biomarker research) in accordance with informed consent and IRB/EC requirements.
• Serve as point of contact for sample-related queries during sponsor, FDA, or IRB audits/inspections.
• Manage biorepository/biobank operations, including long-term storage and material transfer agreements (MTAs).

Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, or related field.
• 8 - 10 years work experience in a drug development organization.
• Experience in clinical trial sample management, biobanking, or central lab operations.
• Working knowledge of GCP and clinical trial regulatory requirements (FDA, ICH).
• Strong organizational skills and attention to detail.
• Computer competency in database and spreadsheet programs.
• Excellent cross-functional communication skills (sites, CROs, labs).
• Familiarity with informed consent and IRB/EC requirements related to specimen retention preferred.
• Experience supporting FDA/sponsor audits or inspections preferred.
• Project management experience across multiple concurrent clinical trials preferred.