Scientific Affairs Specialist II

Scientific Affairs Specialist II - United States (Remote)

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.

We have an incredible opportunity for a Scientific Affairs Specialist II to join ICON’s Scientific Affairs team. The Scientific Affairs Specialist II serves as a key scientific liaison supporting a global central laboratory’s clinical, operational, and commercial activities. This role assists in scientific knowledge and expertise across assay technologies, laboratory services, and clinical trial applications, ensuring scientific rigor, consistency, and alignment with regulatory and customer expectations. The Specialist collaborates cross-functionally with Global Validations, Laboratory Operations, Quality, Regulatory, Business Development, and external stakeholders to support study design, assay implementation, scientific communication, and client engagement.

Location: United States (Remote)

What you will be doing:

• Maintain and configure testing and assay summary information in the Test Master application of the ICOLIMS system
• Configure test codes within the STARLIMS system
• Assist all other ICL departments with Global Scientific Affairs related issues and questions
• Utilize the internet, journals, internal validation documentation, etc. to update specimen requirements, stability, and transport information within departmental databases
• Follow SOPs relevant to Global Scientific Affairs issues
• Provide scientific notifications and technical documentation to Global Client Services
• Assist in scientific consistency across global studies and laboratory sites
• Assigns work from the Scientific Affairs Inbox and assures that all Service Level Agreements for TAT are met
• Lead the collaboration in support of Client Services requests, with regards to special collection instructions
• Attend meetings with both internal and external clients on behalf of Global Scientific Affairs
• Provide notifications of testing changes and updates to ultimately Global Client Services
• Provide scientific input on assay selection and reporting interpretation
• Support troubleshooting of complex scientific or technical issues in collaboration with laboratory and leadership teams
• Act as a scientific point of contact for sponsors, investigators, and internal commercial teams
• Participate in client meetings and scientific consultations
• Identify opportunities to enhance scientific processes and knowledge sharing across the organization
• Support implementation of new technologies, assays, or biomarkers into the central laboratory portfolio

Your profile:

• 5+ years of experience in scientific affairs, central laboratory services, or diagnostics, in a CRO, biotech, or pharmaceutical environment
• Hands-on knowledge of clinical trial laboratory operations and assay methodologies (e.g., immunoassays, molecular assays, flow cytometry, genomics)
• Knowledge of clinical laboratory concepts and terminology
• Experience supporting global or multi-regional clinical studies (preferred)
• Experience with STARLIMS
• Detail-oriented, with strong organizational skills and ability to manage multiple priorities
• Strong scientific and analytical skills with the ability to interpret complex data
• Excellent written and verbal communication skills for both scientific and non-scientific audiences
• Proven ability to collaborate in cross-functional, multicultural, and global teams.
• Proficient in Microsoft Office Suite, specifically Excel
• Bachelors Degree in Medical Technology or related field

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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 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.
• Life assurance
• 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. 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 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.

Are you a current ICON Employee? Please click here to apply