Biospecimen Operations Manager

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.

• Play a key role in the communication and integration of translational medicine objectives with clinical study team members during protocol development and execution.
• Serve as a member of the Translational Medicine clinical study start team; support the tactical execution of biospecimen collection and analysis during clinical protocol development, study start-up and amendments, including contribution to and review of protocols, lab manuals, and clinical laboratory documents and communicate information as required to other departments, take part in program meetings with central lab, clinical, operations and data management.
• Contribute to activities involving the Data Management team, including eCRF set-up, database build for sites and sample tracking/reconciliation.
• Particpiate in efforts to standardize nomenclature, pictograms, sample handling instructions, and resources for all central labs to ensure consistency across studies, welcoming diverse perspectives, and inclusive practices.
• Coordinate with others within Translational Medicine group and external to the group to track and manage samples, projects, and deliverables.
• Aid in the process development and coordination of informed consent form tracking and clinical program sample storage/tracking using in-house and commercial systems.
• Participate in vendor meetings to stay informed of current and upcoming projects, innovative technologies, and vendor offerings.
• Solve problems independently, contacting internal or external clients as needed, while fostering a collaborative and inclusive environment.
• Must be able to prioritize workload in response to the specific needs of numerous protocols and department.
• Maintain awareness of local and international regulations as pertains to protecting the privacy of personal information that may be associated with clinical samples.
• Participate in process improvement initiatives. Plan and implement procedures and systems to maximize operating efficiency.

• Scientific background (BS, RN, Med Tech) with a minimum of 2 years’ experience in clinical drug development, clinical trial execution, central lab study setup with exposure to biomarkers, pharmacokinetics or immunogenicity sample activities including sample collection procedures and logistics considerations, and exposure to informed consent language specific to the handling of human tissue specimens
• An understanding of the drug development process and familiarity with clinical labs and clinical trial sites
• Experience working with Contract Research Organizations (CRO)
• Demonstrated knowledge of ICH and GCP
• Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems and controlled sample management systems
• Detailed and precise record keeping skills are essential as well as the ability to track and resolve issues.
• Must be comfortable with a hybrid role: reporting to Wilmington DE office a few days per week.
• Excellent teamwork and ability to collaborate with cross functional teams.
• Strong interpersonal, written, and verbal communication skills

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.

• 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, Life Works, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are…