Biosample Operations Associate/Sr. Associate in United States Embassy at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Biosample Operations Associate/Sr. Associate based in United States.

The Biosample Operations Associate/Senior Associate will support the operational management of clinical trial biospecimens across the full sample lifecycle.
This role plays a key part in ensuring accurate tracking, documentation, reconciliation, and transfer of clinical samples.
You will collaborate with clinical teams, laboratories, vendors, and cross-functional stakeholders to maintain sample integrity and regulatory compliance.
The position offers the opportunity to help build and scale biosample operations within a growing biotechnology environment.
You will contribute to process improvements, operational excellence, and the successful execution of clinical development programs.
This role is ideal for a detail-oriented professional who enjoys solving problems, improving workflows, and working in a dynamic team setting.

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.

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.

• 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.