Biomarker Sample Operations Lead for Clinical Trials

Planet Pharma; North Chicago (IL); Sur place; USD 41 000 - 55 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Project management

Oncology knowledge

Biomarkers/clinical trials

MS Office

English communication

Time management

Analytical skills

Interpersonal skills

Independent work

PMP

Formation

Master’s degree in related field

Bachelor’s degree in related field

Outils

MS Office Suite

Description du poste

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.