Clinical Study Assistant

KCR Placement; Warszawa; On-site; PLN 256,000 - 335,000; Full time

Benefits offered by this job

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Flexible country-specific benefits

Job summary

ICON Strategic Solutions, a sponsor-dedicated provider, seeks a Clinical Trial Associate to support planning and execution of clinical studies for a pharmaceutical client. You will assist with design analyses, regulatory readiness, and cross-functional collaboration to advance treatments and therapies.

The role emphasizes communication, teamwork, and adherence to global regulatory standards, with travel up to ~10%. ICON highlights competitive salary and benefits within country norms.

Qualifications

• Bachelor's degree in a scientific or healthcare-related field or equivalent international degree.
• 1-2 years’ experience in pharmaceutical industry or CRO as CTA or Study Coordinator.
• Experience in Phase 2/3 studies and global/international studies is advantageous.
• Must have experience in Veeva system.
• Experience working across multiple therapeutic areas, including oncology, is advantageous.

Responsibilities

• Provide support for day-to-day clinical study activities and regulatory inspection readiness under FSP guidance.
• Collaborate with study teams and CROs to support trial activities per the operating model.
• Perform departmental tasks as needed.

Skills

Communication

Teamwork

Attention to detail

Travel readiness

Business English

Education

Bachelor's degree in life sciences

Tools

Veeva system

Job description

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

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here