Director, Specimen Acquisition & Data Management#26-00452
Aliso Viejo, CA
Remote Job Description Director, Specimen Acquisition & Data Management Remote, United States (Hybrid travel/onsite responsibilities may be required.) Job Summary We are seeking an experienced Director of Specimen Acquisition & Data Management to lead the strategic oversight of biospecimen acquisition, specimen lifecycle management, and data governance supporting research and development initiatives. This leadership role is responsible for directing the end-to-end process of acquiring, tracking, processing, storing, and distributing biological specimens while ensuring regulatory compliance, operational efficiency, and data integrity. The Director will collaborate closely with research teams, laboratory operations, pharmaceutical partners, clinical laboratories, and external vendors to ensure timely specimen availability for research projects. This individual will also drive continuous process improvement, oversee enterprise specimen management strategies, and lead high-performing teams responsible for specimen operations and data management. Key Responsibilities
Lead all aspects of biospecimen acquisition, inventory management, tracking, processing, storage, and distribution for research and development programs.
Develop and implement standardized specimen acquisition and management processes across the organization.
Oversee specimen databases, metadata management, and laboratory information systems to ensure accurate tracking throughout the specimen lifecycle.
Ensure compliance with CLIA, CAP, FDA, and other applicable regulatory and quality standards.
Manage specimen logistics, scheduling, labeling, inventory control, and quality assurance activities.
Serve as the primary resource for biospecimen tracking, availability, and reporting.
Build and maintain strategic relationships with hospitals, clinical laboratories, research organizations, pharmaceutical companies, and other external specimen providers.
Lead enterprise vendor management activities, including vendor selection, performance monitoring, contract oversight, and relationship development.
Collaborate cross-functionally with Research & Development, Laboratory Operations, Clinical teams, and external partners to support project timelines and specimen needs.
Drive continuous improvement initiatives that enhance operational efficiency, specimen quality, workflow automation, and data integrity.
Oversee specimen archive operations and ensure proper storage, retrieval, and disposition of biological materials.
Develop reporting tools, dashboards, and performance metrics to monitor specimen operations and project deliverables.
Evaluate and implement new technologies and automated systems to improve specimen management processes.
Recruit, mentor, and develop staff while fostering a culture of accountability, collaboration, and operational excellence.
Requirements
Bachelor's degree in Biology, Medical Technology, Life Sciences, or a related scientific discipline required.
Advanced degree (Master's or Ph.D.) preferred.
Strong knowledge of biospecimen management, laboratory operations, and specimen metadata standards.
Thorough understanding of CLIA, CAP, FDA, and laboratory quality regulations.
Expertise with laboratory information systems (LIS), specimen tracking platforms, and data management systems.
Strong analytical, organizational, and project management skills.
Excellent communication and relationship-building abilities with internal stakeholders and external partners.
Demonstrated leadership, strategic planning, and operational management capabilities.
Advanced proficiency with Microsoft Office and enterprise data management platforms.
Experience
Minimum 10 years of experience in clinical, translational, or academic laboratory operations, biospecimen management, or research support.
At least 5 years of progressive leadership or management experience overseeing laboratory operations, specimen management, or research support teams.
Experience managing biospecimen acquisition programs, specimen repositories, and enterprise specimen logistics.
Proven experience leading cross-functional initiatives involving research, laboratory operations, pharmaceutical organizations, and external vendors.
Experience implementing process improvements, workflow automation, and quality management initiatives.
Background supporting biomarker research, translational medicine, or clinical research programs is highly preferred.
Demonstrated success managing multiple complex projects while ensuring regulatory compliance, operational efficiency, and exceptional service delivery