Biosample Operations Associate/Sr. Associate

About the role

The Biosample Operations Associate/Senior Associate supports the operational management of clinical trial biospecimens across the full sample lifecycle. Key responsibilities include managing biosample operations, ensuring data quality, compliance, and efficient collaboration.

Responsibilities

• Manage critical biosample operations activities while ensuring data quality, compliance, and efficient collaboration across internal and external partners.
• Cook up and oversee biospecimen management activities throughout clinical studies, including collection, shipment, receipt, processing, storage, and transfer workflows.
• Maintain complete and accurate chain-of-custody documentation and ensure sample records are properly tracked across sites, laboratories, and internal systems.
• Support sample inventory management, reconciliation activities, and development of study-specific biosample tracking tools and reports.
• Act as the primary operational contact for central laboratories, specialty testing laboratories, and external vendors regarding sample logistics and study requirements.
• Review laboratory documentation, transfer records, and inventory reports while helping resolve discrepancies, shipment delays, missing samples, and quality issues.
• Perform reconciliation of biosample data across clinical systems, laboratory databases, and sponsor tracking platforms to ensure accuracy and consistency.
• Collaborate with Clinical Operations, Clinical Development, Translational Medicine, Data Management, Regulatory Affairs, and external partners to optimize sample processes.
• Contribute to the creation and improvement of biosample management procedures, SOPs, tools, and scalable operational frameworks.
• Identify opportunities to improve efficiency, visibility, and vendor performance across clinical sample operations.

Requirements

• A Bachelor’s degree in Life Sciences, Biology, Biotechnology, Clinical Research, or a related scientific discipline.
• 2-5 years of experience in clinical research, clinical trial operations, biosample management, laboratory operations, or a related field.
• Experience working with central laboratories, specialty testing laboratories, CROs, or clinical trial vendors is preferred.
• Familiarity with ICH-GCP guidelines and clinical trial operational standards.
• Experience with sample reconciliation, logistics coordination, and vendor management.
• Strong attention to detail with excellent documentation, organizational, and prioritization skills.
• Ability to manage multiple projects and competing priorities independently in a growing organization.
• Strong communication and stakeholder management skills with the ability to collaborate across technical and business teams.
• An analytical mindset with strong problem-solving abilities and experience resolving operational issues.
• Proficiency with Microsoft Office applications and familiarity with clinical trial management systems, laboratory platforms, or sample tracking tools.
• Experience supporting biomarker, PK, PD, immunogenicity, genomic, or translational medicine sample programs is a plus.
• Previous experience in a biotechnology or pharmaceutical environment and familiarity with laboratory information management systems (LIMS) are preferred.

Benefits

• Competitive salary range: Associate level: $104,000 - $125,000 USD annually. Senior Associate level: $130,000 - $146,000 USD annually.
• Competitive benefits package and performance-related bonus opportunities.
• Equity participation opportunities.
• Flexible remote work options or hybrid work arrangements for candidates near designated office locations.
• Opportunity to contribute directly to innovative clinical development programs in a growing biotechnology environment.
• Supportive and inclusive culture focused on collaboration, growth, and professional development.
• Opportunities to build expertise while helping establish scalable operational processes.
• Comprehensive employee benefits designed to support health, financial well-being, and work-life balance.