Biosample Operations Associate/Sr. Associate

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.
• Capture and 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 Process Development

• Partner closely with Clinical Operations, Clinical Development, Translational Medicine, Biometrics, Data Management, Regulatory Affairs, and external vendors.
• Support study startup activities, including review of laboratory manuals, sample collection procedures, laboratory specifications, and sample flow requirements.
• Contribute to the development, implementation, and continuous improvement of biosample management processes, tools, and SOPs.
• Identify operational efficiencies and recommend process enhancements to improve sample visibility, data quality, and vendor performance.
• Help establish scalable biosample operations infrastructure to support the company’s growing clinical development programs.

Qualifications

• Education: Bachelor's degree in Life Sciences, Biology, Biotechnology, Clinical Research, or a related scientific discipline required.
• Experience: 2–5 years of experience in clinical research, clinical trial operations, biosample management, laboratory operations, or a related field.
• Experience: Experience working with central laboratories, specialty testing laboratories, CROs, or clinical trial vendors preferred.
• Knowledge and Skills: Working knowledge of ICH-GCP guidelines and clinical trial operational requirements; understanding of biospecimen collection, processing, storage, shipment, and tracking workflows; strong organizational skills with exceptional attention to detail and documentation accuracy; ability to manage multiple studies and priorities in a fast-paced biotech environment; demonstrated ability to work independently and help build processes in a growing organization; excellent communication and stakeholder management skills; proficiency with Microsoft Office applications and clinical trial management, laboratory, or sample tracking systems; strong analytical, problem-solving, and issue-resolution capabilities.
• Preferred Qualifications: Experience supporting biomarker, PK, PD, immunogenicity, genomic, or translational medicine sample programs; experience in a biotechnology or pharmaceutical company environment, particularly within a small or emerging biotech; familiarity with central laboratory data portals, sample inventory systems, and laboratory information management systems (LIMS); experience supporting clinical studies from startup through study closeout.

Salary Range For the Role

$104,000 - $146,000 USD

What We Offer

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.