Accountabilities

The Biosample Operations Associate/Senior Associate will manage critical biosample operations activities while ensuring data quality, compliance, and efficient collaboration across internal and external partners.

• Coordinate 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.
• Support audit and inspection readiness by maintaining complete biosample documentation and operational records.
• 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

The ideal candidate combines clinical research knowledge, strong organizational abilities, and the ability to operate effectively in a fast-paced biotechnology environment.

• 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.
• Understanding of clinical trial biosample workflows, including collection, processing, storage, shipment, tracking, and chain-of-custody requirements.
• 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.
• 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.