Biosample Operations Specialist
ICON plc
Summary
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise. As a SMA II at ICON, you will support the management and monitor of clinical trial sites by ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
Job description
What You Will Do
You will contribute to clinical research activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include:
- Coordinating monitoring activities at clinical trial sites, ensuring adherence to study protocols and timely resolution of site-related issues.
- Assisting in the preparation and review of regulatory documents, ensuring all site activities are compliant with GCP and applicable regulations.
- Collaborating with cross-functional teams to facilitate effective communication and support for trial sites throughout the study lifecycle.
- Tracking site performance metrics, analyzing data, and providing reports to enhance site management efficiency.
- Participating in training initiatives and mentoring junior staff to support their development in clinical trial management.
Your Profile
You will bring relevant clinical research experience, along with the following qualifications and skills. Required qualifications and experience:
- Bachelor's degree in a relevant field such as life sciences, healthcare administration, or clinical research.
- Experience in clinical research, site management, or monitoring, with a solid understanding of clinical trial processes and GCP guidelines.
- Strong organizational and project management skills, with the ability to handle multiple priorities and deadlines.
- Excellent analytical skills and attention to detail, with a focus on maintaining high-quality standards.
- Exceptional communication and interpersonal skills, with the ability to build and maintain effective relationships with site personnel and cross-functional teams.
- Willingness to travel as required (approximately 25%)
Requirements
- Bachelor's degree in a relevant field such as life sciences, healthcare administration, or clinical research
- Experience in clinical research, site management, or monitoring
- Solid understanding of clinical trial processes and GCP guidelines
- Strong organizational and project management skills
- Excellent analytical skills and attention to detail
- Exceptional communication and interpersonal skills
- Willingness to travel approximately 25%
- Legal right to work in the country where the role is based
Benefits
- Competitive base salary
- Performance incentives
- Medical, Dental & Vision
- Retirement plans
- Pension plans
- Life assurance
- Disability coverage
- Employee assistance programmes
- Wellbeing resources
- Learning and 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.