Biomarker Operations Manager

Biomarker Operations Manager - Remote

Eurofins Scientific is a global leader in life sciences, providing a comprehensive range of analytical testing services to ensure safety, health, and sustainability across various industries. With a vast network of laboratories and a commitment to innovation, Eurofins plays a crucial role in supporting clinical studies and advancing scientific discovery.

About the Role

Eurofins is seeking a motivated Biomarker Operations Manager to join our dynamic Biomarker Operations group. This full-time, remote position is integral to the successful execution of biomarker activities within clinical development programs, spanning early to late stages. While this role does not involve scientific decision-making, it is crucial for ensuring that biomarker strategies are effectively implemented through meticulous sample lifecycle planning, vendor oversight, and cross-functional collaboration.

Key Responsibilities

• Serve as a key member of clinical study teams, providing operational guidance on biomarker sample logistics and vendor management.
• Develop and maintain detailed guidelines for biomarker sample collection, processing, shipping, and long-term storage.
• Track the location and testing status of clinical biomarker samples throughout study completion, ensuring timely data delivery.
• Manage cross-trial biomarker sample testing logistics, coordinating shipment and testing schedules across multiple studies.
• Proactively identify and mitigate operational risks related to biomarker sample logistics, vendor performance, and data delivery.
• Partner with Biomarker Program Leads to co-manage relationships with analytical biomarker laboratories.
• Oversee long-term storage, inventory tracking, and sample destruction.
• Ensure accurate filing of biomarker-related documents within the Trial Master File (TMF).
• Lead and participate in continuous improvement initiatives to enhance operational efficiency.
• Collaborate closely with Clinical Operations, Study Start-Up, Clinical Data Management, laboratory vendors, and CROs to support workflow execution and issue resolution.
• Review biomarker-specific informed consent language and laboratory specifications for accuracy and operational feasibility.

Requirements

• Minimum of 2 years of direct experience with clinical data management.
• Working knowledge of Good Clinical Practice (GCP), clinical trial execution, and stakeholder interactions.
• Demonstrated ability to collaborate effectively with scientists, clinical teams, laboratory vendors, and cross-functional stakeholders.
• Proven ability to independently manage biomarker sample logistics and operational activities across multiple studies.
• Strong computer skills, including proficiency in managing complex sample metadata using tools like Excel, timelines, and PowerPoint.
• Excellent written and verbal communication skills, with strong organizational abilities and attention to detail.
• Must be authorized to work in the United States indefinitely without 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.

What We Offer

• This is a full-time position with a standard work schedule, offering flexibility for early morning meetings.
• Comprehensive benefits package, including medical, dental, and vision coverage.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and company holidays.
• Competitive pay range: $98,000 - $105,000 per year.
• Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
• The position is primarily remote, with a preference for candidates on the West Coast. Seattle-area candidates may have the option for hybrid work.