ICON seeks a Study Start Up Associate II to lead clinical trial initiation activities across European locations. The role involves preparing regulatory documents, coordinating stakeholder approvals, and maintaining trial records while ensuring compliance with clinical research standards.
Responsibilities
- Prepare and submit regulatory documents including clinical trial applications and ethics committee submissions
- Coordinate with internal and external stakeholders to obtain study initiation approvals
- Maintain comprehensive records of regulatory submissions, approvals, and correspondence
- Provide regulatory guidance and support to study teams on start-up best practices
- Participate in process improvement initiatives to enhance study start-up efficiency

Requirements




- Bachelor's degree in life sciences or related field
- Minimum 2 years clinical research or regulatory affairs experience with study start-up focus
- Strong knowledge of ICH-GCP and local regulatory requirements for clinical trials
- Fluency in English, local language, plus German, French, Romanian, or Dutch
- Excellent organizational and project management skills with multitasking ability
- Strong communication and interpersonal skills for cross-functional collaboration
- Willingness to travel approximately 5% as required

📌 Junior Quality Associate (España)
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