Sr CTA
ICON plc
Summary
ICON plc is a global leader in clinical research and healthcare intelligence, founded in Dublin, Ireland in 1990. As one of the world's largest contract research organizations (CROs), ICON provides comprehensive outsourced development services to pharmaceutical, biotechnology, and medical device companies worldwide. The company operates in 55 countries with approximately 41,900 employees, offering end-to-end solutions that span the entire product development lifecycle. ICON's service portfolio includes clinical research services, adaptive trials, biosimilars, commercialization and outcomes consulting, medical imaging, laboratory services, and strategic support for traditional and digital health technologies. The company specializes in therapeutic areas such as oncology, cardiovascular diseases, central nervous system disorders, rare diseases, and women's health. With its 2021 acquisition of PRA Health Sciences, ICON significantly expanded its capabilities and market position, becoming a dominant force in the global CRO industry. The company is publicly traded on NASDAQ under the ticker ICLR and reported $8.28 billion in revenue for 2024.
Job description
What You Will Do
- Clinical study team member: works closely with the Clinical Study Team and is responsible for coordination, logistics, tracking and administrative tasks in support of clinical trials.
- Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects.
- Responsible for filing, review and reconciliation of electronic Trial Master Files.
- Review of study documentation, including study plans, site start-up regulatory pack reviews, monitoring visit reports, ICF documents, etc.
- Supports and/or tracks external access rights to clinical study systems.
- Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific requests and issues.
- Assists CTA/CTM with meeting minutes for clinical meetings.
- Assists CTA/CTM with logistics coordination for investigator meetings and external vendor meetings.
- Responsible for routing, tracking, and coordinating site and CRO/vendor contracts with Clinical Operations, legal, and finance departments.
Your Profile
- Bachelor's degree or equivalent undergraduate degree with science or healthcare experience preferred
- Experience: 2-5 years clinical research experience in a pharmaceutical/biotech, CRO setting preferred
- Basic knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
- Strong interpersonal, organizational, and multi-tasking skills
- Excellent attention to detail and problem solving skills
- Self-motivated and displays initiative
- Perform job duties with minimal supervision and guidance
- Ability to work effectively in a team setting
Requirements
- Bachelor's degree or equivalent undergraduate degree with science or healthcare experience preferred
- 2-5 years clinical research experience in a pharmaceutical/biotech, CRO setting preferred
- Basic knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
- Strong interpersonal, organizational, and multi-tasking skills
- Excellent attention to detail and problem solving skills
- Self-motivated and displays initiative
- Perform job duties with minimal supervision and guidance
- Ability to work effectively in a team setting
Benefits
- Competitive base salary
- Performance incentives
- Medical, Dental & Vision
- Retirement & pension plans
- Life assurance
- Disability coverage
- Employee assistance programmes
- Wellbeing resources
- Learning & development
Company overview
ICON plc is a global leader in clinical research and healthcare intelligence, founded in Dublin, Ireland in 1990. As one of the world's largest contract research organizations (CROs), ICON provides comprehensive outsourced development services to pharmaceutical, biotechnology, and medical device companies worldwide. The company operates in 55 countries with approximately 41,900 employees, offering end-to-end solutions that span the entire product development lifecycle. ICON's service portfolio includes clinical research services, adaptive trials, biosimilars, commercialization and outcomes consulting, medical imaging, laboratory services, and strategic support for traditional and digital health technologies. The company specializes in therapeutic areas such as oncology, cardiovascular diseases, central nervous system disorders, rare diseases, and women's health. With its 2021 acquisition of PRA Health Sciences, ICON significantly expanded its capabilities and market position, becoming a dominant force in the global CRO industry. The company is publicly traded on NASDAQ under the ticker ICLR and reported $8.28 billion in revenue for 2024.