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Senior Study Start Up Associate

ICON Strategic Solutions

Full-time
2-5 years experience
On-site

Key Skills

Clinical Trial Start-Up
Site Activation
Clinical Trial Submissions
Regulatory Submissions
CTIS
Health Authority Approvals
Feasibility Assessments
Site Identification
Site Contract Negotiation
Regulatory Compliance
Ethics Submissions
Informed Consent
Patient Safety
Study Start-Up Planning
Quality Improvement
Stakeholder Collaboration

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

Core Responsibilities

Lead site start-up and activation activities, including feasibility assessments, site identification, contract negotiations, and country-level study initiation planning in the Netherlands. Coordinate regulatory and ethics submissions, support project teams with start-up expertise, and help develop and review informed consent materials while ensuring compliance and patient safety.

Requirements

Candidates need a bachelor's degree or local equivalent, or appropriate medical or scientific experience, and at least three years of experience or understanding of clinical study start-up requirements and activities. Fluency in Dutch and English is essential, along with the ability to work independently, guide others, and travel approximately 5%.

Benefits

  • Annual Leave
  • Health Insurance
  • Retirement Planning
  • Employee Assistance Programme
  • Life Assurance
  • Childcare Vouchers
  • Bike Purchase Schemes
  • Discounted Gym Memberships
  • Subsidized Travel Passes
  • Health Assessments

About ICON Strategic Solutions

Industry: Pharmaceutical Manufacturing

Company size: 10,001+ employees

ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services. Through combined functional, operational, and talent expertise, ICON offers FSP models that provide cost-savings, clinical expertise and significantly improve business performance. Follow us for the latest industry insights as well as vacancies and insight into life at ICON.

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