New · posted Nov 1
Abbott · Medical Devices
Sr. Clinical Affairs Specimen Operations Specialist
- Madison, WI +1 more
- On-site
- Full-time
- Senior & Principal
The role
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.
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.
What you need
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 Qualificationsnice to have
- 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.
What you'll do
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.
Pay
$78,000 – $156,000 a year
Employer providedThe base pay for this position is
$78,000.00 – $156,000.00
In specific locations, the pay range may vary from the range posted.
Where you'll work
Madison, WI +1 moreOn-siteOpen in Maps (opens in a new tab)
Also posted for: San Diego, CA
More jobs in Madison, WI +1 moreWorking conditions
Standard
TRAVEL
Yes, 10 % of the Time
MEDICAL SURVEILLANCE
No
JOB FAMILY
Supply Chain
DIVISION
ONCO Cancer Diagnostics
LOCATION
United States > Madison : 5505 Endeavor Ln
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% below the US median for Clinical Operations roles at this level.
This roleEmployer provided
Senior & Principal roles in the US14 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $78,000 | — | $156,000 |
| All US (middle half) | $120,750 | $143,000 | $153,875 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Clinical Operations roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Operations
The general path across 93 open Clinical Operations roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Career resources on Clinical Operations
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership7
- Lab testing and methods4
- Quality systems and risk4
- Clinical trial conduct4
- Documentation and SOPs3
- GMP and compliance2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Abbott on Regulatory Jobs
- 108
- Open roles
- 98
- Distinct roles
- 32
- Locations
By discipline
- Quality61 56%
- Regulatory30 28%
- Clinical16 15%
By level
- Senior & Principal50 46%
- Associate & Specialist33 31%
- Manager21 19%
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Sr. Clinical Affairs Specimen Operations Specialist at Abbott
Open until filled. $78K–$156K a year, employer provided.