16 sep
|
Icon Clinical
|
Madrid
16 sep
Icon Clinical
Madrid
Experteer Overview
In this role, you lead clinical trial start-up activities, ensuring regulatory compliance and enabling timely study initiation. You will work within cross-functional teams to prepare submissions, obtain authorizations, and maintain accurate regulatory records. You contribute to process improvements to streamline start-up workflows and support the wider mission of advancing innovative therapies. This position offers exposure to global regulatory practices and meaningful impact on patient access to new treatments.
Compensaciones / Beneficios
• Lead preparation and submission of regulatory documents (CTA, ethics committee submissions, regulatory agency communications)
• Coordinate with internal and external stakeholders to secure approvals for study initiation
• Maintain comprehensive records of submissions, approvals, and correspondence
• Provide guidance on regulatory requirements and best practices for start-up activities
• Participate in process improvement initiatives to increase start-up efficiency
Responsabilidades
• Bachelor's degree in Life Sciences or related field
• Minimum 2 years in clinical research or regulatory affairs with study start-up experience
• Strong understanding of ICH-GCP and local regulatory requirements
• Excellent organizational and project management skills
• Excellent communication and cross-functional collaboration abilities
• Willingness to travel (~5%)
Requisitos principales
• annual leave entitlements
• health insurance offerings
• retirement planning
• Integral Employee Assistance Programme LifeWorks
• Life assurance
• flexible country-specific benefits
📌 Study Start Up Associate (Madrid)
🏢 Icon Clinical
📍 Madrid