Senior Study Start Up Associate

IRE

3d

About The Position

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.

Requirements

• 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%).
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Nice To Haves

• 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.

Responsibilities

• Lead on site start-up and activation tasks requiring technical depth, with a focus on quality and continuous improvement.
• Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities.
• Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success.
• Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines.
• 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.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Senior