Biosample Operations Specialist (Site Management Associate) - Home-Based

As a Biosample Operations Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The Biosample Operations Specialist is responsible for overseeing the biomarker laboratory samples for the client's clinical trials across the chain of custody from research site to the analysis laboratory. This role supports Study Teams across the portfolio of therapeutic areas.

What you will be doing:

• Accountable for planning, coordinating and overseeing all operational activities required to manage the lifecycle of biomarker samples (oversight of sample collection at site, shipment to vendor for testing/processing, analysis and final sample disposition) ensuring sample integrity and GCP compliance throughout the process
• Collaborates with study teams and biomarker scientists to develop biological sample management plans in concurrence with sites, and central and specialized laboratories for all biomarker samples
• Reviews clinical study protocols, informed consent forms, laboratory documents, case report forms and service provider laboratory scope of work documents for sample handling details
• Interfaces with laboratory personnel, sample processing and other vendors to ensure proper shipment and receipt of samples, responding to issues as needed to ensure study objectives for clinical biomarkers are met
• Interfaces with laboratory personnel, sample processing and other vendors to ensure proper shipment and receipt of samples, responding to issues as needed to ensure study objectives for clinical biomarkers are met
• Works closely with study teams to manage monitoring of appropriate patient consent for all biosample collection and testing
• Ensures compliance with European GDPR requirements for personal information transmitted with biosamples

You are:

• Bachelor's degree in Biochemistry, Chemistry, Biology, Immunology, Medical Technology or related life sciences field preferred
• Experience working in a laboratory, research site and/or clinical trial management role at a biopharma company
• Working knowledge of FDA & ICH/GCP regulations
• Proven critical reasoning and problem solving skills
• Ability to oversee sample management activities across multiple projects, while maintaining electronic tracking system
• Excellent written, organizational and interpersonal communication skills necessary to collaborate and interface with outside vendors, consultants, and internal study team members (scientists, clinicians, clinical trial managers)
• Proficiency in Microsoft Office Applications including Excel, Word and PowerPoint

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.