Senior Clinical Specimen Operations Lead

Thornton Tomasetti; Madison (WI); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott is seeking a Sr. Clinical Affairs Specimen Operations Specialist to lead planning and execution of specimen logistics for clinical studies.

This onsite role can be based in Madison, WI or San Diego, CA, and requires 7+ years in clinical trial operations, with CAPM certification preferred. The role emphasizes strategic leadership, cross‑functional execution, and continuous improvement across processes, tools, and workflows while ensuring adherence to FDA/ICH GCP standards and budget

Qualifications

• Bachelor’s degree in health or life sciences, supply chain, engineering, or a related field relevant to specimen logistics or clinical operations.
• 7+ years of experience in clinical trial operations, specimen or sample management, logistics, supply chain, or related operational support of clinical studies.
• 3+ years of experience in a project management support role.

Responsibilities

• Leads operational planning and strategic management of specimen logistics for assigned clinical studies, ensuring supply, collection, shipment, receipt, processing, storage, and reconciliation meet protocol and regulatory standards.
• Translates study requirements into actionable specimen operations plans, coordinating timelines, deliverables, and execution with clinical, laboratory, program, and external partners.
• Manage and analyze key specimens and supply performance metrics to identify risks, opportunities, and data‑driven improvements supporting reliable study delivery.
• Provide guidance, coaching, and knowledge sharing to less‑experienced team members on specimen operations processes, tools, and best practices within clinical research.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.

Skills

Cross-functional coordination

Project management

Clinical trial operations

Regulatory knowledge

Education

Bachelor’s degree in health or life sciences, supply chain, engineering, or related field

Tools

CAPM

Clinical systems

Job description

Abbott is seeking a Sr. Clinical Affairs Specimen Operations Specialist to lead planning and execution of specimen logistics for clinical studies.

This onsite role can be based in Madison, WI or San Diego, CA, and requires 7+ years in clinical trial operations, with CAPM certification preferred. The role emphasizes strategic leadership, cross‑functional execution, and continuous improvement across processes, tools, and workflows while ensuring adherence to FDA/ICH GCP standards and budget