Biomarker Operations Manager (Oncology)

TL;DR

Biomarker Operations Manager (Oncology): Managing operational execution and logistics for biomarker and translational sample operations in oncology clinical studies with an accent on sample lifecycle management and vendor coordination. Focus on optimizing sample logistics, ensuring regulatory compliance (GCP/GLP), and integrating biomarker strategies into clinical trial activities.

Location: Plainsboro, NJ, USA

Salary: $155,800 – $166,400

Company

hirify.global is a staffing and recruiting firm specializing in providing technical and scientific talent for the healthcare and life sciences industries.

What you will do

• Implement and execute clinical biomarker, translational sample, and companion diagnostic strategies across projects.
• Manage sample logistics and operations for oncology clinical studies, coordinating with central laboratories and specialty lab vendors.
• Oversee the full biomarker sample lifecycle, including collection, processing, analysis, data transfer, and final disposition.
• Provide operational expertise and guidance to cross-functional project teams and clinical trial teams.
• Perform site and laboratory feasibility assessments regarding sample collection, handling, and storage.
• Review and draft laboratory specifications, manuals, and SOPs for investigator sites and study monitors.

Requirements

• Bachelor’s degree or an equivalent combination of education and experience.
• Minimum of 3+ years of relevant industry experience.
• Strong knowledge of oncology clinical trials and translational medicine.
• Solid understanding of ICH, GCP, GLP, and regulatory requirements related to biomarker samples.
• Hands-on experience managing biomarker and sample logistics within pharmaceutical, biotech, or CRO environments.
• Must be located in or able to work onsite in Plainsboro, NJ.

Culture & Benefits

• Major medical, dental, and vision insurance plans.
• 401k retirement plan options.
• Statutory sick pay where required.
• Commitment to reasonable accommodations for individuals with disabilities.
• Inclusive hiring practices regardless of criminal history in accordance with local laws.