Study Start Up Associate II (German-Speaker)

ICON Clinical Research; Warszawa; Remote; PLN 45,000 - 65,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

LifeWorks

Life assurance

Childcare vouchers

Job summary

ICON Clinical Research in Poland is seeking a Study Start Up Associate II (German-Speaker) to drive site initiation and regulatory submissions for clinical trials, working remotely from Poland. You will coordinate with cross-functional teams, manage regulatory documents, ethics submissions, and timelines, ensuring accuracy and compliance throughout the study start-up process.

Fluency in English and German (plus French or Romanian) and a life sciences degree are required; prior clinical research

Qualifications

• Fluent in English and German, with French or Romanian as optional.
• Bachelor's degree in life sciences or related field.
• Clinical research or regulatory affairs experience preferred.

Responsibilities

• Deliver site start-up and activation work to a high standard.
• Assist in preparation and submission of regulatory documents (CTA and ethics submissions).
• Coordinate with internal and external stakeholders to obtain approvals.
• Maintain accurate records of regulatory submissions and approvals.
• Support study teams in documents like protocols and informed consent forms.

Skills

English & German fluency

Education

Bachelor's degree in life sciences

Job description

Study Start Up Associate II (German-Speaker) - Poland - Remote

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Study Start Up Associate II at ICON, you will facilitate the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

Your role will involve delivering site start-up and activation work to a high standard, working closely with your team and stakeholders.

Key responsibilities include:

• Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.
• Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
• Maintaining accurate and up-to-date records of regulatory submissions and approvals.
• Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.
• Participating in study start-up meetings and providing input on regulatory requirements and timelines.

Your Profile:

You will bring relevant site start-up and activation experience, along with the following qualifications and skills.

Required qualifications and experience:

• Professional fluency in English and German + French or Romanian
• Bachelor's degree in life sciences or a related field.
• Previous experience in clinical research or regulatory affairs preferred, but Nt required.
• Strong attention to detail and organizational skills.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.

#LI-DK2

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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations)