Sr. Clinical Affairs Specimen Operations Specialist

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 a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

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, elevate 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 $78,000.00 – $156,000.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Supply Chain DIVISION: ONCO Cancer Diagnostics LOCATION: United States > Madison : 5505 Endeavor Ln ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

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