Head of Operations Management (m/w/d)
ICON
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.
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.
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.
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. 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)
Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems and controlled sample management systems
Must be comfortable with a hybrid role: reporting to Wilmington DE office a few days per week.
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.
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.
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. 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.
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