Biomarker Operations Specialist

As a Biomarker Operations Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

In this position you will coordinate timelines and activities for biomarker projects and communicate across all relevant departments to ensure high quality and timely delivery of biomarker results. This role will closely collaborate with biomarker leads, clinical trial operations, medical, data management, biostatistics, and external laboratory vendors/CROs. Core duties of this role include biomarker sample operational logistics, clinical trial support, and management of biomarker vendors.

What you will be doing:

• Work with colleagues in Biomarkers and Imaging for the implementation of biomarkers in pre-clinical validation and clinical studies to meet program goals through a translational understanding of the disease state and treatment modalities
• Maintain close contact with the Biomarker and Imaging program leadership to communicate biomarker activities
• Serve as a key member of clinical study execution teams, providing input and guiding clinical implementation of biomarkers
• Develop biomarker sample handling guideline for sample processing and manage aspects of biomarker sample collection and consent
• Track and trigger analyses of biomarker clinical samples to completion and data transfers according to established timelines
• Resolve biomarker sample related questions from sites, CROs, clinical operations, and ethics committees with cross-functional team input (e.g. stability, sample usage, storage duration)
• Manage work with CROs on biomarker assays (for pre-clinical development or for clinical trials) including contract management, scope of work, lab manual, biomarker analysis plan, development of timelines, and oversight of deliverables
• Responsible for long term storage and destruction of biomarker samples from clinical or exploratory studies
• File expected biomarker documents in sponsor Trial Master File (TMF)
• Review clinical trial study documents including study dossier, version control tracker, vendor management plan, and Action Decisions Risks log and update as applicable.
• Creates template documents for Biomarker Operations team as well as training materials for new team members
• Perform budget review and oversight of assigned project(s)
• Contribute to and assist driving biomarker process improvement initiatives forward
• Assist with on-boarding and training new Biomarker Operations team members

You are:

• BS in Biology or related field with approximately 2-4 years of experience or the equivalent combination of education and experience
• Excellent written and oral communication; organized and detail-oriented; ability to prioritize and plan
• Knowledge and understanding of general scientific principles as applied to biomarker research, development, and implementation
• Knowledge of Good Clinical Practices, clinical study design and implementation is a plus but not required

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

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.