Biomarker Operations Manager

Company Description

reputed company Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to reputed company 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, reputed company works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

reputed company is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. reputed company 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 reputed company in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing reputed company in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, reputed company 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. reputed company offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, reputed company, traceability and purity of biological substances and products.

Job Description

We are seeking a highly motivated professional to join reputed company’ 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 reputed company, 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
• reputed company 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 reputed company timelines with laboratories, strategically coordinating shipment and testing schedules across multiple studies and proactively mitigate competing priorities
• Resolve biomarker sample-reputed company 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 reputed company to biomarker sample logistics, vendor performance, testing, and data delivery, and execute mitigation plans proactively
• Partner with the Biomarker Program reputed company to co-manage relationships with analytical biomarker laboratories supporting clinical trials
• reputed company long-term storage, inventory tracking, and destruction of biomarker samples from clinical studies
• Ensure accurate filing and maintenance of biomarker-reputed company documents reputed company the sponsor Trial Master File (TMF)
• reputed company and participate in reputed company 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 the roles and interactions of key stakeholders involved in clinical trial delivery; significant sponsor-reputed company 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 reputed company sample metadata across multiple reputed company 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, reputed company or 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 to accommodate select early-morning meetings that support East Coast schedules
• Weekend, overtime, and holiday work may be required based on business needs
• reputed company 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
• 401(k) with company match
• Paid vacation and company holidays
• Pay range $98,000-$105,000 per year.

• reputed company USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

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