Biomarker Operations Manager

Job Title: Manager, Biomarker Operations

Job Description

We are seeking a skilled Manager for Biomarker Operations who possesses experience in clinical operations and a comprehensive understanding of central and analytical laboratory processes. The ideal candidate will ensure the quality planning, implementation, and execution of biomarker operations throughout the specimen lifecycle. This includes strategic setup of central lab operations, study start-up, logistics, and clinical sample management from collection through testing and final sample disposition.

Responsibilities

• Plan and coordinate operational activities through the biomarker specimen lifecycle.
• Set up central and analytical labs pertaining to biomarker collections.
• Prepare and review clinical study documents such as lab specification documents, sample management plans, and laboratory manuals.
• Support vendor selection and contract review.
• Develop site trainings for biomarker collections.
• Manage biomarker specimens from collection through testing and final disposition.
• Ensure compliance with Clinical Protocol and Informed Consent.
• Maintain chain of custody for specimens.
• Organize and oversee the collection, shipping, storage, and maintenance of clinical specimens.
• Resolve or triage specimen queries from sites or vendors.
• Ensure proper documentation of specimen destructions is obtained and filed appropriately.
• Collaborate on the implementation and maintenance of a specimen tracking system.
• Work collaboratively with internal key stakeholders to ensure proper alignment and execution of scientific and operational needs.
• Support internal vendor leads with central and analytical lab oversight and process improvements.
• Identify, develop, and implement risk mitigation strategies associated with lab vendors as needed across programs.

Essential Skills

• Project management experience in clinical operations.
• Vendor management experience.
• Knowledge of GxP and applicable regulatory requirements.
• Strong technical skills and capability to lead infrastructure assessment and improvement.
• Biomarker sample management and lab management experience.
• Planning and coordinating operational activities through the biomarker specimen lifecycle.
• Bachelor’s degree required.
• 3-5 years of related experience dependent on skills and education.
• Proficiency with data sets and Excel, understanding of data relationships and metadata.
• Excellent written and verbal communication skills.
• Detail-oriented with a focus on quality and accuracy.
• Strong interpersonal skills; encourages collaboration and effective communication.
• Technologically savvy and adaptable to new tools and methods.

Additional Skills & Qualifications

• MSc in Life Science.
• PMP certification.
• Previous biobanking, sample tracking, and handling experience.
• Previous LIMS experience.
• Working knowledge of the clinical drug development process.
• Working knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, and UAT.
• Oncology experience or working knowledge.

Work Environment

This is a 100% remote role supporting West Coast operations. The team is fully remote, offering flexibility and the opportunity to work across various time zones. The team is supportive of global trials and encourages a collaborative and communicative work culture. The position involves managing a mixture of full-time employees and contractors. The team values collaboration, communication, timeliness, and attention to detail, and aims for continuous improvement and simplification of processes.

This is a Contract position based out of Bothell, WA.

The pay range for this position is $60.00 - $72.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully remote position.

This position is anticipated to close on Mar 10, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $60 - $72