ICON Strategic Solutions · 1 day ago
CRA I
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Pharmaceutical Manufacturing
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Responsibilities
Lead and manage activities related to the design, coordination, and execution of clinical research studies focused on in vitro diagnostics.
Ensure clinical studies and monitoring visits are conducted and documented in compliance with study protocols, site monitoring SOPs, applicable regulations and the principles of ICH/GCP as appropriate.
Validate product performance claims and support critical regulatory submissions.
Qualification
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Required
Bachelor's degree in relevant field.
At least 2 years of hands-on experience in as a medical technologist in infectious diseases.
Proficiency in serum testing.
Experience working with tissue samples, analyzers and diagnostic instruments.
Familiarity with specialized testing procedures and laboratory workflows.
Experience with laboratory information systems (LIS) or other data management software.
Ability to adapt to new systems and technologies efficiently.
Strong attention to detail and ability to troubleshoot technical issues independently.
Excellent communication and collaboration skills.
Preferred
Prior CRA experience is a plus.
Certification as a Medical Technologist by ASCP or equivalent preferred but not required.
Benefits
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
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.