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Senior CTA

Overview

As a Clinical Trial Assitant based in the Netherlands you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

 

Responsibilities

Responsibilities:

  • Assists in coordination and administration of clinical studies from the start-up to execution and close out
  • Collects, assists in preparation, reviews, and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study. Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
  • Serves as local administrative main contact and works closely with the CRAs for the duration of the study.
  • Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.
  • Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.
  • Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
  • Contributes to the production and maintenance of study documents, ensuring template and version compliance.

Qualifications

  • High school/Secondary school qualifications (*), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
  • Previous administrative experience preferably in the medical/ life science field.
  • Proven organizational and administrative skills.
  • Computer proficiency.
  • Good knowledge of spoken and written Dutch and English. 

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 maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

 

 

#LI-IB4

#Hybrid

 

Average salary estimate

$70000 / YEARLY (est.)
min
max
$60000K
$80000K

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What You Should Know About Senior CTA, UNAVAILABLE

Are you ready to take your career to the next level as a Senior Clinical Trial Assistant at ICON? Located in the vibrant Netherlands, you’ll be a part of the world’s largest and most comprehensive clinical research organization, supported by the latest healthcare intelligence. In this engaging role, you'll assist with the coordination and administration of clinical studies from their inception through execution to closeout. This includes collecting and preparing key documents, ensuring timely submissions to ethical committees and regulatory authorities, and serving as a key point of contact for investigators and external partners. If you thrive in a fast-paced environment and have a knack for organization, this position is perfect for you! You will also oversee the local electronic Trial Master File (eTMF) and the essential document tracking processes, guaranteeing everything adheres to ICH-GCP standards. With your strong administrative skills and proficiency in both Dutch and English, you will ensure inspection readiness at all times. ICON values your contributions and offers a range of benefits aimed at nurturing your talent and ensuring your well-being. Join us at ICON, where our diverse culture and commitment to high performance empower us to serve our communities better. Don’t miss this opportunity to advance your career while making a difference in clinical research!

Frequently Asked Questions (FAQs) for Senior CTA Role at UNAVAILABLE
What does a Senior Clinical Trial Assistant do at ICON?

As a Senior Clinical Trial Assistant at ICON, your responsibilities include coordinating and administering clinical studies, collecting and preparing essential documents for submission to regulatory bodies, and maintaining the electronic Trial Master File (eTMF). You'll support research activities and work closely with investigators and external partners to ensure everything runs smoothly throughout the study lifecycle.

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What qualifications are required for a Senior Clinical Trial Assistant at ICON?

To be considered for the Senior Clinical Trial Assistant position at ICON, candidates should ideally possess a secondary school qualification that supports the necessary skills for effective performance. Previous administrative experience, especially in medical or life sciences, and strong organizational abilities are crucial. Proficiency in spoken and written Dutch and English is also required.

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What benefits does ICON offer to Senior Clinical Trial Assistants?

ICON offers a competitive salary along with a variety of benefits tailored for Senior Clinical Trial Assistants. These include annual leave entitlements, comprehensive health insurance options, retirement planning support, wellness programs like a Global Employee Assistance Programme, and flexible benefits such as childcare vouchers and discounted gym memberships, all aimed at promoting well-being and work-life balance.

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What is the work culture like at ICON for Senior Clinical Trial Assistants?

At ICON, the work culture is inclusive, diverse, and focused on high performance. Senior Clinical Trial Assistants are encouraged to collaborate, innovate, and contribute to a supportive environment that values different perspectives. You'll find respect and equality as core principles, which enhance teamwork and ultimately improve outcomes for our patients and communities.

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Can I apply for the Senior Clinical Trial Assistant position if I don't meet all the qualifications at ICON?

Absolutely! ICON encourages candidates who may not meet all explicit qualifications to apply for the Senior Clinical Trial Assistant role. You may possess skills and experiences that align perfectly with what ICON seeks. The organization values diverse backgrounds and believes that there’s a good chance you could be the ideal fit for this or other roles.

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Common Interview Questions for Senior CTA
What experience do you have in coordinating clinical trials as a Senior Clinical Trial Assistant?

When answering this question, provide specific examples from past roles where you coordinated and administered clinical trials. Discuss your involvement in document management, adherence to regulatory compliance, and collaboration with different stakeholders, showcasing your organizational skills and attention to detail.

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How do you ensure compliance with ICH-GCP guidelines in your role?

Illustrate your understanding of ICH-GCP guidelines and discuss how you’ve implemented them in previous roles. Highlight specific procedures you followed, like maintaining the eTMF or timely document submission, and emphasize your ability to keep teams informed about compliance standards.

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Can you describe your experience with electronic Trial Master Files (eTMF)?

Share your experiences working with eTMFs, detailing any specific software you are familiar with and your role in maintaining their accuracy and integrity. Discuss how you ensure that all essential documents are uploaded and maintained for inspection readiness.

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How do you prioritize tasks when managing multiple clinical studies?

Explain your approach to task prioritization, including any tools or methods you use to manage competing deadlines. Highlight your ability to stay organized and adaptable when the workload fluctuates, ensuring efficient project progression.

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What strategies do you use to maintain effective communication with investigators and external service providers?

Discuss your communication style and give examples of how you have maintained positive relationships with stakeholders. Emphasize your proactive approach in providing updates, addressing inquiries, and facilitating smooth collaboration toward study objectives.

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How do you handle challenges or setbacks in a clinical trial environment?

Give a specific example of a challenge you faced and how you addressed it. Emphasize your problem-solving skills, ability to remain calm under pressure, and your commitment to ensuring that the trial continues on track.

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What software tools do you find most effective in your day-to-day tasks?

Cite specific software tools that you have used to manage clinical trial documents, track progress, and ensure compliance. Demonstrate your tech-savviness and comfort with various systems that enhance efficiency in your role as a Senior Clinical Trial Assistant.

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How would you ensure that all study documents are ready for final archiving?

Explain your process for ensuring documents are collected, reviewed, and properly indexed for final archiving. Mention your attention to detail and the importance you place on maintaining a robust documentation trail that fulfills regulatory and quality assurance standards.

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What motivates you to succeed in the role of Senior Clinical Trial Assistant at ICON?

Share personal motivations that drive your performance, such as a passion for patient care, a commitment to advancing medical research, or a love for problem-solving. Connect these motivations to how they align with ICON's values and mission.

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How do you stay updated on changes in regulations related to clinical trials?

Talk about your commitment to professional development, including how you seek out training, attend relevant networking events, or follow industry news. Show a proactive approach to staying informed about regulatory changes that impact your work.

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DEPARTMENTS
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
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HQ LOCATION
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EMPLOYMENT TYPE
Full-time, hybrid
DATE POSTED
April 12, 2025

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