Senior Study Start Up Associate

ICON Clinical Research; Netherlands; Remote; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Annual leave

Retirement planning

Employee assistance program

Life assurance

Job summary

ICON Strategic Solutions, part of ICON plc, seeks a Senior Study Start Up Associate to support the Study Start Up Team Lead in the Netherlands, driving site initiation and activation in a fast-paced sponsor-dedicated environment.

You will lead regulatory submissions, site identification, contract negotiations, and master/country-specific consent materials, ensuring patient safety and compliance while collaborating with international teams.

Qualifications

• Minimum 3 years in clinical study start-up activities.
• Experience with Netherlands regulatory processes and approvals.
• Fluency in Dutch and English for cross-border collaboration.

Responsibilities

• Drive Study Initiation: feasibility, site identification, and contract negotiation.
• Provide SSU expertise to leads and project teams for success.
• Coordinate regulatory submissions to authorities and ethics bodies.
• Contribute to patient information sheets and informed consent review.

Skills

SSU experience

Regulatory submissions

Clinical trials

Team leadership

Education

Bachelor's degree

Job description

SSU Support

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 Senior Study Start Up Associate at ICON, you will be working within a large-scale, fast-paced environment, supporting the Study Start Up Team Lead in developing and execute the plan for country and site distribution in the Netherlands.

We are looking for candidates with experience in Clinical Trial Submissions for the Netherlands to acquire approval from Health Authorities and via the CTIS application to start-up new assigned clinical trials.

What You Will Do:

You will lead on site start-up and activation tasks requiring technical depth, with a focus on quality and continuous improvement.

Key responsibilities include:

• Efficiently Drive Study Initiation: Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities.
• Empower Success through Specialized SSU Expertise: Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success.
• Ensuring Regulatory Compliance: Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines.
• Safeguarding Patient Welfare: Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent.

Your Profile:

You will have a strong foundation in site start-up and activation, with the experience to work independently and guide others.

Required qualifications and experience:

• A Bachelor's degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline.
• At least 3 years of experience or understanding of clinical study start-up requirements and activities, showing your expertise in the field.
• Fluency in the local language and English is essential, enabling you to effectively communicate and collaborate with international teams.
• Willingness to travel as required (approximately 5%)

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)