Clinical Sample Operations Specialist

Danaher Corporation•Chaska, MN

6d•Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? Within Danaher the work our diagnostic businesses do saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. We’re accelerating the development of cutting-edge diagnostics to solve some of the world’s most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. We’re bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we’re expanding access to precision diagnostics for millions of people worldwide - and we’re using our unmatched global scale and proven playbook to make it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we’re improving treatment options and saving lives. Learn about the Danaher Business System which makes everything possible. The Clinical Sample Operations Specialist is responsible for support the clinical development programs by performing high-quality specimen accessioning, processing, storage, retrieval, and distribution within a regulated IVD development environment. This role ensures accurate, compliant, and efficient handling of biological specimens and contributes directly to the timely execution of clinical study activities across the organization. This position reports to the Senior Manager Global Clinical Procurement and is part of Danaher Diagnostic’s Clinical Center of Excellence (CCOE) organization located in Chaska, MN – United States and will be an on-site position. In this role, you will have the opportunity to: Receive, verify, access, and process biological specimens (sorting, aliquoting, labeling, storage) in accordance with established quality and procedural requirements.

Requirements

Bachelor’s degree in life sciences, health sciences, biotechnology, or a related field.
2+ years of experience in specimen handling, biorepository operations, clinical research coordination, or biospecimen logistics.
Hands‑on experience with sample accessioning, chain of custody, and inventory tracking using spreadsheets or LIMS.
Proven ability to prepare and review sample shipment documentation and follow detailed SOPs within a regulated environment.
Strong organizational, time‑management, and attention‑to‑detail skills to accurately manage high‑throughput workloads.

Nice To Haves

Knowledge of regulatory and ethical standards related to clinical sample handling, such as GCP, FDA 21 CFR Part 11, ICH-GCP, and IRB/ethics requirements.
Strong organizational and documentation skills, with attention to detail in tracking samples and verifying paperwork.
Proficiency with Excel, Google Sheets, or basic LIMS platforms (e.g., FreezerWorks, LabVantage, OpenSpecimen).
The ability to prioritize tasks, follow SOPs, and work independently in a time-sensitive, regulated environment.
Comfortable working in cold storage environments (e.g., ULT freezers) and following proper PPE/safety protocols.

Responsibilities

Maintain accurate chain‑of‑custody records and timely entry of specimen data into laboratory information systems to ensure traceability and compliance.
Organize, route, retrieve, re‑archive, and distribute specimens to internal teams and external sites to support ongoing and ad hoc clinical program needs.
Prepare, package, and ship specimens in compliance with biosafety, regulatory, and quality management system (QMS) guidelines, resolving and documenting any specimen issues.
Maintain inspection‑ready biorepository operations, including inventory, supplies, storage systems, and work areas, while contributing to continuous process improvements.