Biosample Operations Associate/Sr. Associate

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.

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.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1