Biomarker Operations Manager
- Full-time
- Compensation: USD 65000 - USD 80000 - yearly
Company Description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
Job Description
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
Qualifications
- Bachelor’s degree (BS) in Biology or a related scientific field with 6 or more years of relevant experience, or an equivalent combination of education and experience
- Excellent written and verbal communication skills; highly organized, detail‑oriented, and able to prioritize effectively in a fast‑paced environment
- Strong understanding of scientific principles as applied to biomarker research, development, and clinical implementation
- Working knowledge of Good Clinical Practices (GCP) and clinical study design and execution
- Demonstrated ability to collaborate effectively with scientists, clinical teams, vendor laboratories, and cross‑functional stakeholders
- Ability to independently oversee biomarker sample logistics and operational activities across multiple studies and programs
- Strong data and computer skills are required, including a demonstrated ability to manage complex datasets, timelines, and operational tracking tools
- Smartsheet experience is strongly preferred, and/or demonstrated proficiency with project management platforms, data tracking systems, and reporting tools used to support clinical operations
- Experience scripting in R is preferred
- Authorization to work in the United States indefinitely without restriction or sponsorship
Additional Information
- Position is full-time, Monday- Friday 8:00-5:00 pm.
- May be requested to work on weekends, overtime, and holidays based on business needs.
- Candidates currently living within a commutable distance of Seattle, WA are encouraged to apply.
- Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.