Sr. Clinical Affairs Specimen Operations Specialist

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 122000 colleagues serve people in more than 160 countries.

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 datadriven 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 lessexperienced 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 companys 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

• Bachelors 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 crossfunctional 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

$78000.00 $156000.00

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

Supply Chain

ONCO Cancer Diagnostics

United States > Madison : 5505 Endeavor Ln

Standard

Yes 10 % of the Time

No

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: EEO is the Law link - Espanol: Experience:

Senior IC