Sr. Clinical Affairs Specimen Operations Specialist

JOB DESCRIPTION:

Position Overview

The Sr. Clinical Affairs Specimen Operations Specialist leads planning and execution of specimen logistics for clinical studies, ensuring that supply, sample handling, and associated data flows reliably support study designs, evidence generation, and portfolio needs. This role leads cross-functional execution of commercial and pipeline studies, applying operational, scientific, and strategic expertise to ensure logistical readiness, optimize specimen operations, and deliver clinical programs on time, within budget, and aligned with business objectives. The role requires exceptional adaptability, critical thinking, complex problem-solving skills, and strong logic and judgment in the analysis and navigation of complex problems. It also provides subject-matter support to junior team members.

The ideal candidate is a strategic, influential leader with strong relationship building skills, deep clinical specimen operations expertise, and a proven ability to drive organizational impact. They navigate complex programs, align diverse stakeholders, translate overarching business objectives into scalable operational strategies, and proactively manage risks and opportunities. Recognized as a trusted partner and subject matter expert, they mentor others, champion operational excellence, and drive continuous improvement across processes, tools, and ways of working.

This is an onsite role and can be based in our Madison, WI or San Diego, CA office location.

Essential Duties

Include, but are not limited to, the following:

• 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 (e.g., kit usage, sample quality, chain of custody, turnaround times) to identify risks, opportunities, and data‑driven improvements supporting reliable study delivery.
• Problem-solves and resolves specimen and logistics issues, applying sound judgment to prioritize actions, escalate when needed, and ensure timely resolution in line with established procedures.
• Lead continuous process improvement, contributing to workflow documentation, standard practices, and initiatives that enhance efficiency, consistency, and scalability across studies.
• Provides guidance, coaching, and knowledge sharing to less‑experienced team members, serving as a resource on specimen operations processes, tools, and best practices within clinical research.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to travel 10% of working time away from work location, may include overnight/weekend.

Minimum 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.
• Demonstrated experience coordinating cross‑functional activities, applying working knowledge of project management principles to support execution across multiple studies or initiatives.
• 3+ years of experience in a project management support role.

Preferred Qualifications

• 2+ years of experience in process and workflow design, and process improvement.
• Certified Associate in Project Management (CAPM) through PMI.
• Strong understanding of FDA regulations and ICH GCP.
• Understands global regulations.
• Good understanding of clinical systems functionality and requirements.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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