Biomarker Operations Manager (Oncology)

Location: Plainsboro, New Jersey 08536, United States

Salary: $166,400 per year

Company

hirify.global provides staffing and professional services for life sciences and other industries.

What you will do

• Support the implementation and execution of biomarker, translational sample, and companion diagnostic strategies across oncology clinical studies.
• Manage clinical and biomarker sample logistics with clinical trial teams, central laboratories, and specialty laboratory vendors.
• Coordinate the full biomarker sample lifecycle, including collection, processing, analysis, data transfer, data cleaning, and final disposition.
• Provide operational guidance to cross-functional teams and support site and laboratory feasibility assessments.
• Review laboratory specifications, manuals, and sample-handling materials, and support training for investigator sites and study monitors.
• Coordinate with internal stakeholders and external partners to ensure operational readiness and successful study execution.

Requirements

• Bachelor’s degree or an equivalent combination of education and experience.
• At least 3 years of relevant industry experience in pharmaceutical, biotechnology, or CRO environments.
• Strong knowledge of oncology clinical trials, biomarkers, and translational medicine in clinical development.
• Understanding of clinical research processes, including ICH, GCP, GLP, regulatory requirements, and legal considerations for biomarker samples.
• Hands-on experience managing biomarker and sample logistics operations.
• Experience working with SOPs, guidance documents, work instructions, and biomarker-related documentation.

Nice to have

• Strong project coordination, organizational, written, and verbal communication skills.
• Experience collaborating with scientists, trial managers, data managers, clinicians, and laboratory vendors.
• Ability to manage multiple priorities in a fast-paced clinical development environment.

Culture & Benefits

• Cross-functional collaboration with clinical, scientific, data, and laboratory stakeholders.
• Temporary assignments lasting 13 weeks or longer may include medical, dental, vision, and 401(k) benefits.
• Statutory sick pay is provided where required.
• Reasonable accommodations are available during the employment process.