Site Specialist II
ICON · Sofia, Bulgaria +2 more
Clinical OperationsFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
This role involves managing site-level regulatory and operational activities for clinical trials across DACH regions, including documentation coordination, study start-up support, and regulatory compliance under EU CTR. The ideal candidate brings clinical research experience, fluent German and English, and demonstrated expertise in EU clinical trial requirements and site support processes.
What they're looking for
- Bachelor's degree in life sciences, healthcare, or related discipline
- Previous site support, activation, or clinical trial operations experience in CRO or pharma
- Hands-on experience with EU Clinical Trials Regulation processes and requirements
- Knowledge of clinical trial documentation, GCP, and site-level regulatory requirements
- Fluent in German and English with strong written and verbal communication
- Strong organizational skills managing multiple sites and competing priorities
- Proactive, solution-focused approach collaborating with sites and cross-functional teams
What you'll be doing
- Coordinate collection, review, and maintenance of essential site documentation for compliance
- Support site start-up and regulatory activities per EU CTR and Swiss CTD requirements
- Serve as operational contact for DACH investigator sites on documentation and processes
- Track site progress, milestones, and actions within clinical trial management systems
- Collaborate with cross-functional teams to resolve issues impacting site timelines
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.