Study Start up Associate II
ICON · Budapest, Hungary
Clinical OperationsFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Lead clinical trial initiation activities at this global research organization, managing regulatory submissions, stakeholder coordination, and study start-up documentation. Ensure compliance with regulatory requirements while supporting site activation and process improvements.
What they're looking for
- 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
- Excellent organizational and project management skills for multiple concurrent tasks
- Strong communication and cross-functional collaboration abilities
- Willingness to travel approximately 5% as required
What you'll be doing
- Prepare and submit regulatory documents including trial applications and ethics committee submissions
- Coordinate with internal and external stakeholders to obtain necessary approvals and authorizations
- Maintain comprehensive records of regulatory submissions, approvals, and correspondence
- Provide guidance to study teams on regulatory requirements and start-up best practices
- Participate in process improvement initiatives to enhance study start-up efficiency
Privacy & handoff
This role links to ICON's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.