Biomarker Operations Manager at Eurofins

We are seeking a highly motivated professional to join Eurofins’ Biomarker Operations group to work in a dynamic and cross‑functional environment spanning early‑ to late‑stage clinical development. The Biomarker Operations Manager acts as an important contributor to the clinical development of novel therapies and supports high‑quality, compliant execution of biomarker activities. This is a hybrid role based in Seattle, requiring approximately 2-3 days/week onsite attendance. Onsite presence is as needed / as required and may fluctuate based on business needs, study demands, and project timelines. In this position, you will coordinate timelines and activities for biomarker projects to ensure high‑quality and timely delivery of biomarker results and maintain close contact with Biomarker and Imaging program leadership to communicate activities. This role collaborates closely with biomarker leads, clinical trial operations, medical, data management, biostatistics, and external laboratory vendors and CROs. Core duties include biomarker sample operational logistics, clinical trial support, and vendor management. Responsibilities • Work with colleagues in the Biomarkers Department for the implementation of biomarkers in pre‑clinical validation and clinical studies to meet program goals through a translational understanding of disease states and treatment modalities • Serve as a key member of clinical study execution teams across multiple disease area programs, providing input and guidance on clinical implementation of biomarkers • Develop biomarker sample handling guidelines for sample processing and manage aspects of biomarker sample collection and informed consent • Track, manage, and trigger analyses of biomarker clinical samples through completion, including oversight of data transfers according to established timelines • Resolve biomarker sample‑related questions from investigational sites, CROs, clinical operations, and ethics committees with cross‑functional input (e.g., stability, sample usage, storage duration) • Manage work with CROs and external laboratories on biomarker assays (pre‑clinical development, validation, and clinical trials), including: • Contract and scope of work management • Lab manuals and biomarker analysis plans • Development and maintenance of timelines • Oversight of deliverables and issue resolution • Oversee long‑term storage, inventory tracking, and destruction of biomarker samples from clinical and exploratory studies • Ensure accurate filing of biomarker‑related documents within the sponsor Trial Master File (TMF) • Review clinical trial documents for biomarker‑related content and update as applicable • Lead and participate in continuous process improvement initiatives, including operational efficiencies and data quality enhancements • Review sections of clinical study protocols, biomarker strategy documents, and biomarker study reports with appropriate supervision • Train and advise junior biomarker operations colleagues on best practices, systems usage, and issue resolution