Biomarker Operations Manager

Company Description:

Eurofins Scientific is a global leader in life sciences, offering a comprehensive range of analytical testing services across multiple industries. With a network of 900 laboratories in over 50 countries and 55,000 staff, Eurofins provides over 200,000 analytical methods to ensure the safety, identity, composition, authenticity, origin, traceability, and purity of biological substances and products. We are committed to making life and our environment safer, healthier, and more sustainable.

The Role:

Eurofins' Biomarker Operations group seeks a highly motivated Biomarker Operations Manager to join a dynamic, cross-functional team supporting 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 ensures that scientific strategy is delivered effectively through sample lifecycle planning, vendor coordination, and cross-functional collaboration. You will serve as a clinical study team member 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 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.

Responsibilities:

• Partner with colleagues across the Biomarkers Department to support biomarker implementation in clinical studies and advance program goals.
• Serve as a key member of clinical study teams, 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 timelines.
• Manage cross-trial biomarker sample testing logistics, develop timelines with laboratories, and strategically coordinate shipment and testing schedules.
• Resolve biomarker sample-related questions from investigational sites, CROs, Clinical Operations, and Ethics Committees.
• Review biomarker-specific informed consent language for accuracy regarding sample collections, permissions, and storage.
• Review laboratory specifications and manuals to ensure protocol-defined biomarker sample requirements are accurate and operationally feasible.
• Identify operational risks related to biomarker sample logistics, vendor performance, testing, and data delivery, and execute mitigation plans.
• Partner with the Biomarker Program Lead to co-manage relationships with analytical biomarker laboratories.
• Oversee long-term storage, inventory tracking, and destruction of biomarker samples.
• 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.

Qualifications:

Minimum Qualifications:

• At least 2 years of direct experience with clinical data management.
• Working knowledge of Good Clinical Practice (GCP), clinical trial execution, and stakeholder interactions; 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, including managing complex sample metadata across Excel files, timelines, PowerPoint summaries, and operational tracking tools.
• Excellent written and verbal communication skills, strong organizational skills, attention to detail, and ability to prioritize effectively.
• 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 (e.g., Smartsheet, LIMS).
• Experience with scripting in R.

Additional Information:

• This is a full-time position, Monday through Friday, 8:00 a.m. to 5:00 p.m., with flexibility for early-morning meetings.
• Weekend, overtime, and holiday work may be required.
• West Coast candidates are preferred. The position may be fully remote or hybrid for Seattle-area candidates.
• Comprehensive full-time benefits, including medical, dental, and vision coverage, life and disability insurance, and 401(k) with company match.
• Paid vacation and company holidays.
• Pay range: $98,000-$105,000 per year.

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.