Biomarker Sample Operations Manager III

Planet Pharma; North Chicago (IL); On-site; USD 41,000 - 55,000; Full time

Job summary

Planet Pharma seeks a Biomarker Sample Operations Manager to oversee the collection, transfer, and testing of clinical trial biomarker specimens. You will collaborate with clinical operations, project managers, and the laboratory manager to ensure timely, compliant sample handling and data integration across studies.

The role emphasizes process improvement, vendor oversight, and adherence to ICH/GCP guidelines, with minimal supervision and a focus on oncology biomarker programs.

Qualifications

• Master’s degree with 3+ years project management, oncology/biomarkers experience.
• Bachelor’s degree with 4+ years project management, oncology/biomarkers experience.
• Proficiency in MS Office (Excel, Word, PowerPoint).
• Excellent oral and written communication in English.
• Strong organization, attention to detail and time management with adaptability.
• PMP certification is a plus.
• Clinical trial experience.
• Scientific background in oncology.
• Ability to work with minimal supervision.

Responsibilities

• Plan and oversee collection and shipping of bio-samples to assay labs.
• Partner with Biomarker Program Manager and Biomarker Lead Scientist to meet study timelines.
• Ensure timely shipments to vendors and correct data transfer to databases.
• Review study documents and create edit checks for sample types.
• Manage relationships with lab vendors and assess service level commitments; resolve issues.
• Help with contract execution and vendor oversight in compliance with procedures.
• Develop and implement a sample tracking system; adhere to ICH/GCP and bio-storage procedures.
• Mentor team members and participate in process improvement; document training materials.
• Balance multiple priorities in a fast-paced, team-based environment; work independently when needed.

Skills

Project management

Oncology knowledge

Biomarkers/clinical trials

MS Office

English communication

Time management

Analytical skills

Interpersonal skills

Independent work

PMP

Education

Master’s degree in related field

Bachelor’s degree in related field

Tools

MS Office Suite

Job description

Target PR Range: 30-40/hr
*Depending on experience

Purpose:

The Precision Medicine group uses advanced methods to discover biomarkers for use in clinical trials. The Biomarker Sample Operations Manager works closely with clinical operations, project managers and laboratory managersto ensure timely and smooth collection, transfer and testing of clinical trial biomarker specimens in compliance with protocols, regulatory requirements and project timelines. This role is responsible for identifying projects/tasks together with laboratory managers and works with biomarkerstudy management teams to complete tasks. This role will drive innovation and continuous improvement activities in bio-sample collection, processing and transfers, and demonstrate ability to carry out all bio-sample operations with minimal supervision.

Responsibilities:

• Plan, organize and oversee the collection and shipping of bio-samples from investigator sites or centralized locations and subsequent delivery to assay laboratories.Partner with Biomarker Program Manager and Biomarker Lead Scientist to ensure the delivery of bio-sample data in accordance with study timelines. Ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases for each assigned study, reconcile sample information stored in databases
• Responsible for functional process and system improvements to ensure samples are collected,

processed, analyzed, transported, stored and destroyed appropriately

• Review study-specific documents related to sample collection, handling, analysis, transport and storage as assigned. Create edit checks for each sample type within assigned trials

• Manage relationships with laboratory vendors, provide input into trial-specific docs and assess

service level commitments of labs involved in sample analysis. Ensure issues are resolved or

escalated in a timely manner. Review lab vendor invoices to ensure work has been completed.

Help project managers with contract execution and vendor oversight in compliance withprocedures and applicable regulations. May oversee laboratory vendor deliverables

against the scope of work

• In partnership with Biomarker Program Managers, Biomarker Lead Scientists and IT, contribute to the development and implementation of a sample tracking system for assigned studies
• Apply and adhere to ICH/GCP, bio-storage procedures, bio-sample management best practices

and ethical guidelines

• Develop into a subject matter expert (SME) and resource for one or more processes in BPM
• Participate in process improvement initiatives or improving efficiency as needed, as well as

instructions and manuals for internal training purposes

• Contribute to a positive and motivating work environment that encourages mutual respect,

innovation and accountability at all levels mentor and develop team members as needed

• Balance multiple priorities in a fast-paced, team-based environment and work independently when needed

Qualifications:

• Master’s Degree with 3+ years project management, knowledge of oncology, including biomarkers and/or clinical trial experience
• Bachelor’s Degree with 4+ years of project management, knowledge of oncology, including biomarkers and/or clinical trial experience
• Expertise in MS Office applications including Excel, Word and PowerPoint
• Excellent oral and written communication skills in English
• Organization, attention to details and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills
• PMP certification a plus
• Clinical trial experience
• Scientific background and knowledge of oncology
• Ability to work with minor supervision