[Hiring] Clinical Biospecimen Scientist @ICON plc

Role Description

Working fully embedded within a growing, global healthcare company, you will be responsible, with appropriate oversight from the Lead CBS, for the implementation and end-to-end operational execution of each GCO clinical study strategy as it relates to selected biospecimens samples.

Accountabilities

• Contribute to providing input on clinical sample assessment sections in clinical trial-related documents (such as protocols and consents).
• Create study-specific sample collection tables and ensure alignment with blood volumes needed versus allowed.
• Liaise with internal stakeholders to provide input into the SSWs for safety and PK sample collection and testing needs.
• Responsible to set up and oversee the technical aspects of all laboratories involved in kit building, sample management and testing, including all related documentation such as lab manuals.
• Contribute to providing input and solutions on the ethical considerations for biospecimen collections and analyses for protocols and consents.
• Responsible for sample management and logistics with appropriate oversight from the Lead CBS.

Risk Management

• In collaboration with the Lead CBS, ensure proper escalation of any identified trial specific risks and issues related to biospecimen collection and analysis in conjunction with relevant line functions.

Qualifications

• Previous CRO or vendor experience.
• Must have human sample management, not just in-vitro sample management or animal testing management.
• Must have an understanding of providing input on clinical sample assessments and requirements.
• Must have a background in understanding the design of a lab from the trial protocol perspective and would need to have systems experiences with the central labs to understand the build as well as Data transfer specification.
• Education: Science degree.
• Lab background in terms of sample management, sample processing, understanding the assay requirements for the samples required for the assigned study.
• Kit design and protocol contribution.
• Must be open and able to communicate across multiple departments and line functions.
• Biospecimen management: Understand the requirement of collection of samples and which timepoints they are collected/analyzed and data is analyzed.

Benefits

• 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.