Scientific Affairs Specialist I

ICON plc

3d • Remote

About The Position

Scientific Affairs Specialist I - 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 I to join ICON’s Scientific Affairs team. The Scientific Affairs Specialist I 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)

Requirements

• 2+ 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
• 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

Nice To Haves

• Experience supporting global or multi-regional clinical studies (preferred)
• Experience with STARLIMS

Responsibilities

• 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

Benefits

• 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, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees