Biosample Operations Specialist

Biosample Operations Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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

Your Profile:

• 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

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, 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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply