Job Title: Biosample Operations Associate/Senior Associate

Location: Remote or Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required.

Role Overview:

The Biosample Operations Associate/Senior Associate is responsible for supporting the operational management of clinical trial biospecimens throughout the sample lifecycle. This role serves as the primary liaison between investigative sites, central laboratories, specialty testing laboratories, clinical operations, and study vendors to ensure the accurate tracking, transfer, reconciliation, and documentation of clinical trial samples.

The Biosample Operations Associate/Senior Associate oversees chain-of-custody processes and sample logistics from collection at clinical sites through shipment to central laboratories and onward transfer to specialty or third-party testing laboratories. This position does not involve direct handling of biological specimens but requires close collaboration with internal and external stakeholders to ensure sample integrity, regulatory compliance, and data quality.

As a member of a growing biotechnology company, this individual will play a key role in building, optimizing, and scaling biosample operational processes. The ideal candidate is comfortable working in a dynamic environment, identifying process improvements, and helping establish best practices that support an expanding clinical development portfolio.

Key Responsibilities:

Biosample Lifecycle Management

• Coordinate and oversee biospecimen management activities across clinical studies.
• Monitor sample collection, shipment, receipt, processing, storage, and transfer activities performed by external laboratory vendors.
• Ensure complete and accurate chain-of-custody documentation throughout the sample lifecycle.
• Track sample inventories and reconcile sample records between investigative sites, central laboratories, specialty laboratories, and sponsor tracking systems.
• Support the development and maintenance of sample tracking tools, reports, and study-specific biosample management plans.

Laboratory and Vendor Management

• Serve as the primary operational contact for central laboratories and specialty testing laboratories regarding biosample logistics and study requirements.
• Coordinate sample transfers between laboratories to support biomarker, PK, PD, immunogenicity, genomic, and exploratory research testing.
• Review laboratory documentation, sample transfer records, and inventory reports for completeness and accuracy.
• Escalate and assist in resolving sample discrepancies, missing samples, shipment delays, temperature excursions, and chain-of-custody issues.
• Support oversight of laboratory vendors to ensure compliance with study requirements and timelines.

Data Reconciliation and Quality Oversight

• Perform routine reconciliation of biosample data across laboratory databases, EDC systems, IRT systems, and sponsor tracking tools.
• Investigate and document sample-related discrepancies and support corrective and preventive actions when necessary.
• Maintain biosample metrics and generate study status reports for cross-functional stakeholders.
• Support inspection and audit readiness by ensuring complete and accurate biosample documentation and records.

Cross-Functional Collaboration and Pro