Clinical Study Assistant at ICON plc in Poland, Warsaw

Clinical Study Assistant

Location: Poland, Warsaw · Remote

POL-HB-CTA

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Clinical Trial Associate at ICON, 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.

What You Will Do:

We are currently seeking a Clinical Trial Associate to join our diverse and dynamic team. Working as a Clinical Study Assistant, exclusively assigned to a Pharmaceutical Company, you will perform tasks related to the planning and execution of clinical studies.

Key responsibilities include:

• Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the Functional Service Provider (FSP) Manager and in collaboration with FSP CTA Manager(s)
• Collaborate with Clinical Operations/Study Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model
• Perform departmental tasks as needed

Accountabilities:

• Review of study documentation, including essential document packets, study plans, informed consent forms
• Supporting/oversight of risk-based monitoring
• Attendance of key team meetings as required, including Minutes for selected studies
• Supporting regulatory inspection readiness (e.g. SOP Lists, storyboard collation)
• Support clinical trial systems (e.g. CTMS/TMF) and associated activities for selected studies
• Supporting vendor contract administration as required
• Support study close-out activities, e.g. financial reconciliation
• Supporting additional ad-hoc activities as needed, as agreed with Manager(s)
• Collaboration with internal departments (Legal, Insurance, R&D functions, etc.), CROs, and external vendors

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 scientific or healthcare-related field or equivalent international degree required
• 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
• Must have experience in 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
• Excellent teamwork, organizational, interpersonal, and problem-solving 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%)

#LI-DD1

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply