Clinical Bio-Specimen Scientist - Remote (East Coast)

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.

Responsible for the implementation and end-to-end operational execution of each GCO clinical trial strategy as it relates to all biosepcimens collected, including safety, pharmacokinetics, biomarkers and companion diagnostics, in compliance with sponsor processes and regulatory and ethical requirements.

With oversight from the Clinical Biospecimen Lead Scientist, contribute to all technical and operational biospecimen-related matters for assigned projects in collaboration with internal stakeholder and line funtional representatives

What you will be doing:

• Provide input on clinical sample assessment sections in clinical trial-related documents (such as protocols and consents) in collaboration with the line functional representatives.
• Create study specific sample collection tables and ensure alignment with blood volumes needed versus allowed.
• Responsible to set up and oversee the technical aspects for all laboratories involved in kit building, sample management, and testing, including all related documentation such as lab manuals.
• Provide input and solutions on the ethical considerations for biospecimen collections and analyses for protocols and consents to ensure that all specific processes needed for approval in different countries are implemented.
• Responsible for sample management and logistics throughout the biospecimen lifecycle; includes ensuring timely analysis, proper consent, and oversight of samples, in collaboration with data management.
• Define sample needs for the case report forms (CRFs) and data transfer in collaboration with internal stakeholders, trial data managers (TDMs), and analysis labs
• Adhere to GCO processes, SOPs and ICH/GCP gudelines
• Successful interactions in a matrix environment, getting input from internal stakeholders and the clinical teams to implement the sample logistics within the required timelines.
• Prepare or contribute to study specific documents within established timelines.
• Facilitate timely transportation of samples with appropriate annotation to analysis labs to ensure timely delivery of data
• Timely, efficient and quality execution of biospecimen related activities for assigned clinical trials
• Proactive operational planning with effective contingency and risk mitigation plans

You are:

• Bachelors degree required
• Collaborate with EDO/vendor management on oversight of all labs.
• Collaborate with internal stakeholders to understand biospecimen strategy.
• Key member of a study team to ensure biospecimens are collected, analyzed and data transferred as per the clinical protocol.
• Human/biospecimen sample management experience
• Experience with risk and issue management
• Central lab and study set up experience

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 maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.