Biomarker Sample Operations Manager III_35514

K3-Innovations, Inc.; Illinois; On-site; USD 100,000 - 150,000; Full time

Job summary

K3-Innovations, Inc. in Illinois is seeking an experienced Biomarker Sample Operations Manager to support a precision medicine program focused on clinical trials and biomarker initiatives.

You will collaborate with Clinical Operations, Project Managers, Laboratory Managers, and Lead Scientists to ensure timely collection, testing, and compliant handling of biomarker specimens, while improving processes and tracking systems.

Qualifications

• Master’s degree with 3+ years of project management experience in biomarker or clinical trial operations.
• Bachelor’s degree with 4+ years of project management experience in related fields.
• Scientific background and knowledge of oncology and biomarker programs.
• PMP certification is a plus.
• Strong organizational and interpersonal skills.

Responsibilities

• Plan, organize, and oversee collection and shipment of biological samples to assay labs.
• Collaborate with program managers and lead scientists to meet study timelines.
• Manage shipments to vendors and storage sites, reconciling sample data across databases.
• Drive process and system improvements for sample collection, processing, testing, and storage.
• Review study documentation related to sample handling, analysis, transport, and storage.
• Develop and implement sample tracking systems; oversee vendor relationships and oversight.

Skills

Project management

Analytical skills

Interpersonal skills

Communication skills

Attention to detail

Education

Master's degree in a relevant field

Bachelor's degree in a relevant field

Tools

MS Excel

PowerPoint

Word

Job description

We are seeking an experienced Biomarker Sample Operations Managers to join a Precision Medicine team supporting clinical trials and advanced biomarker programs.

This role will work closely with Clinical Operations, Project Managers, Laboratory Managers, Biomarker Program Managers, and Lead Scientists to ensure the timely and compliant collection, transfer, testing, and management of clinical trial biomarker specimens.

Responsibilities

• Plan, organize, and oversee the collection and shipment of biological samples from investigator sites or centralized locations to assay laboratories
• Partner with Biomarker Program Managers and Lead Scientists to ensure delivery of biomarker sample data according to study timelines
• Ensure timely shipments to vendors and storage sites and reconcile sample information across databases
• Drive process and system improvements covering sample collection, processing, analysis, transportation, storage, and destruction
• Review study-specific documentation related to sample collection, handling, analysis, transportation, and storage
• Create edit checks for sample types within assigned clinical trials
• Manage relationships with laboratory vendors and assess service-level commitments
• Support vendor oversight, contract execution, deliverables, and invoice review
• Partner with Biomarker Program Managers, Lead Scientists, and IT on the development and implementation of sample tracking systems
• Apply ICH/GCP, biostorage procedures, biomarker sample management best practices, and ethical guidelines
• Develop subject matter expertise in biomarker sample operations and contribute to process improvement and training initiatives
• Balance multiple priorities in a fast-paced, team-based environment while working independently when needed

Qualifications

Master’s degree + 3+ years of project management experience, with knowledge of oncology, biomarkers and/or clinical trials

OR

Bachelor’s degree + 4+ years of project management experience, with knowledge of oncology, biomarkers and/or clinical trials

• Scientific background and knowledge of oncology
• Strong project management, analytical, organizational, and interpersonal skills
• Excellent attention to detail and ability to manage changing priorities
• Strong written and verbal communication skills
• Proficiency with MS Excel, Word, and PowerPoint
• Ability to work with minimal supervision
• PMP certification is a plus

Desired Experience

Biomarker Operations | Clinical Trial Samples | Precision Medicine | Biospecimen Management | Sample Tracking | Laboratory Operations | Clinical Operations | Oncology | Vendor Management | Project Management | ICH/GCP

If you have experience managing clinical trial biospecimens and biomarker sample operations and enjoy working cross-functionally in a fast-paced clinical research environment, we'd love to hear from you!