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Biosample Operations Specialist

ICON Strategic Solutions

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Original Job Summary

About ICON Strategic Solutions

ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment that drives innovation and excellence, inviting you to join our mission to shape the future of clinical development.

Role Overview

The Biosample Operations Specialist is responsible for overseeing biomarker laboratory samples across clinical trials. You will manage the chain of custody from the research site to the analysis laboratory, ensuring sample integrity and GCP compliance, and support study teams across various therapeutic areas.

Key Responsibilities

  • Plan, coordinate and oversee operational activities for biomarker sample lifecycle.
  • Collaborate with study teams and biomarker scientists to develop sample management plans.
  • Review clinical study protocols, informed consent forms and laboratory documents.
  • Interface with laboratory personnel and vendors to ensure proper shipment and receipt of samples.
  • Monitor patient consent for biosample collection and testing.
  • Ensure compliance with European GDPR requirements for biosample related data.

Your Profile

  • Bachelor's degree in Biochemistry, Chemistry, Biology, Immunology, Medical Technology or related field.
  • Experience in a laboratory, research site or clinical trial management role.
  • Working knowledge of FDA & ICH/GCP regulations.
  • Strong critical reasoning, problem solving and organizational skills.
  • Excellent written and interpersonal communication capabilities.
  • Proficiency in Microsoft Office Applications including Excel, Word, and PowerPoint.

What ICON Can Offer You

Along with a competitive salary, ICON offers a broad benefits package focused on work-life balance, health insurance, retirement planning and various flexible, country-specific options.

Key skills/competency

  • Biomarker samples
  • Clinical trials
  • GCP compliance
  • Sample lifecycle
  • Study coordination
  • Regulatory knowledge
  • Laboratory operations
  • Data integrity
  • Vendor management
  • Microsoft Office

How to Get Hired at ICON Strategic Solutions

🎯 Tips for Getting Hired

  • Tailor your resume: Customize your skills for ICON Strategic Solutions.
  • Highlight regulatory expertise: Emphasize GCP and GDPR compliance.
  • Show technical proficiency: Include laboratory and data tracking experience.
  • Prepare for interviews: Research ICON culture and study team dynamics.

📝 Interview Preparation Advice

Technical Preparation

Review GCP and FDA guidelines.
Study biomarker sample protocols.
Practice electronic tracking systems.
Refresh Microsoft Office skills.

Behavioral Questions

Describe problem-solving in complex projects.
Explain conflict resolution with vendors.
Detail teamwork in clinical environments.
Discuss handling compliance challenges.