Description
As a Clinical Trial Associate at ICON Strategic Solutions in Warsaw, Poland, you will assist with the design and analysis of clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.
Key responsibilities include:
- Providing support for critical day-to-day clinical study activities, including regulatory inspection readiness
- Collaborating with Clinical Operations/Study Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities
- Performing departmental tasks as needed
Accountabilities:
- Reviewing study documentation, including essential document packets, study plans, informed consent forms
- Supporting/oversight of risk-based monitoring
- Attending key team meetings as required, including Minutes for selected studies
- Supporting regulatory inspection readiness
- Supporting clinical trial systems and associated activities for selected studies
- Supporting vendor contract administration as required
- Supporting study close-out activities, e.g. financial reconciliation
- Collaborating with internal departments, CROs, and external vendors
You will bring relevant clinical research experience, along with the following qualifications and skills:
- Bachelor's degree in a scientific or healthcare-related field or equivalent international degree
- 1-2 years' experience in pharmaceutical industry, clinical research organization as CTA or Study Coordinator
- Experience in Phase 2 and 3 studies and global/international studies is advantageous
- Experience working with Veeva system
- Experience working across multiple therapeutic areas (including oncology) is advantageous
- Knowledge in global/regional regulatory and compliance requirements for clinical research
- Demonstrated excellence in task management and cross-functional collaboration
- Excellent communication skills
- Fluent business English (oral and written)
- Ability to work collaboratively in a fast-paced environment with attention to detail
- Willingness to travel as required (approximately 10%)
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.