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).Ability to oversee sample management activities across multiple projects, while maintaining electronic tracking system.Proven critical reasoning and problem solving skills.Working knowledge of FDA & ICH/GCP regulations.
Experience working in a laboratory, research site and/or clinical trial management role at a biopharma company.Bachelor's degree in Biochemistry, Chemistry, Biology, Immunology, Medical Technology or related life sciences field preferred.Ensures compliance with European GDPR requirements for personal information transmitted with biosamples.Works closely with study teams to manage monitoring of appropriate patient consent for all biosample collection and testing.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.Reviews clinical study protocols, informed consent forms, laboratory documents, case report forms and service provider laboratory scope of work documents for sample handling details.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.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.This role supports Study Teams across the portfolio of therapeutic areas. 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. ICON people have a mission to succeed and a passion that ensures what we do, we do well. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. ICON plc is a world-leading healthcare intelligence and clinical research organisation.
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