We are seeking a highly motivated professional to join Eurofins’ Biomarker Operations group in a dynamic, cross-functional environment spanning early- to late-stage clinical development.
This is a full-time remote role. Candidates based in the Seattle, WA area may elect to attend onsite up to two days per week.
The Biomarker Operations Manager is responsible for the operational planning and logistics required to execute biomarker activities for clinical projects. This role does not own biomarker strategy or scientific decision-making; instead, it ensures that strategy is delivered effectively through rigorous sample lifecycle planning and oversight, vendor coordination, and cross-functional collaboration. In this position, you will serve as a clinical study team member responsible for coordinating biomarker sample logistics and vendor operations, ensuring compliant sample collection, processing, storage, and timely delivery to analytical laboratories. You will partner with Biomarker Program Leads to align operational execution with strategic objectives and collaborate closely with Clinical Operations, Study Start-Up, Clinical Data Management, laboratory vendors, and CROs to support workflow execution, risk mitigation, and issue resolution across clinical trials.
Responsibilities
- Partner with colleagues across the Biomarkers Department to support biomarker implementation in clinical studies and advance program goals through a translational understanding of disease states and treatment modalities
- Serve as a key member of clinical study teams across multiple disease-area programs, providing operational guidance on biomarker sample logistics and vendor management
- Develop and maintain biomarker sample handling guidelines for collection, processing, shipping, and long-term storage
- Track clinical biomarker sample location and testing status through study completion, ensuring data delivery aligns with study-specific timelines
- Manage cross-trial biomarker sample testing logistics and develop timelines with laboratories, strategically coordinating shipment and testing schedules across multiple studies and proactively mitigate competing priorities
- Resolve biomarker sample-related questions from investigational sites, CROs, Clinical Operations, and Ethics Committees with appropriate cross-functional input
- Review biomarker-specific informed consent language to ensure accurate description of sample collections, permissions for future research, and long term storage duration,
- Review laboratory specifications and laboratory manuals to ensure protocol-defined biomarker samples, intended use, logistics, and storage are accurate and operationally feasible
- Identify operational risks related to biomarker sample logistics, vendor performance, testing, and data delivery, and execute mitigation plans proactively
- Partner with the Biomarker Program Lead to co-manage relationships with analytical biomarker laboratories supporting clinical trials
- Oversee long-term storage, inventory tracking, and destruction of biomarker samples from clinical studies
- Ensure accurate filing and maintenance of biomarker-related documents within the sponsor Trial Master File (TMF)
- Lead and participate in continuous improvement initiatives focused on operational efficiency and process excellence
Minimum Qualifications
- At least 2 years of direct experience with clinical data management
- Working knowledge of Good Clinical Practice (GCP), clinical trial execution, and the roles and interactions of key stakeholders involved in clinical trial delivery; significant sponsor-side experience supporting clinical trials is required
- Demonstrated ability to collaborate effectively with scientists, clinical teams, laboratory vendors, and cross-functional stakeholders
- Ability to independently manage biomarker sample logistics and operational activities across multiple studies and programs
- Strong computer skills are required, including demonstrated ability to manage complex sample metadata across multiple Excel files, timelines, PowerPoint summaries, and operational tracking tools
- Excellent written and verbal communication skills, with strong organizational skills, attention to detail, and the ability to prioritize effectively in a fast-paced environment
- Authorization to work in the United States indefinitely without restriction or sponsorship
Preferred Qualifications
- General Understanding of biomarker research, development, and clinical implementation
- Advanced proficiency with project management platforms or sample tracking systems (for example, Smartsheet or LIMS)
- Experience with scripting in R
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
