Overview
In this role you will monitor clinical studies at investigative sites and ensure compliant conduct, data integrity, and study reporting. You will set up and oversee study activities, including site identification, regulatory submissions, and initiation visits. Working in a smaller CRO, you’ll influence outcomes, collaborate cross-functionally, and benefit from strong management support. Your work will contribute to advancing precision medicine in oncology and rare diseases.
Leistungen / Benefits
- remote work
Verantwortungsbereiche
- Monitor progress of clinical studies at investigative sites to ensure protocol, SOP, ICH-GCP, and regulatory compliance
- Coordinate study setup and monitoring activities (identify investigators, prepare regulatory submissions, conduct pre-study and initiation visits)
- Ensure accurate recording and reporting of study data per protocol and standards
- Maintain effective communication with sites, study teams, and stakeholders
- Support travel as required (up to 50-60% for some roles)
Zentrale Anforderungen
- Graduate or postgraduate degree in a scientific or healthcare discipline
- At least one year as a CRA in CRO or pharmaceutical/biotech industry or equivalent
- Site management or equivalent clinical research experience
- Excellent communication and organizational skills
- Team player with client-focused approach
- Fluency in English and German
- Availability for domestic travel (up to 50-60%); international travel for senior roles can be required
- Experience in oncology
- calm, thoughtful and responsive under pressure
- well-prepared and proactive (investigator meetings, site visits, project updates)
- strong problem-solving and creative thinking to overcome difficulties
- ICH-GCP compliance knowledge
- regulatory submissions support
- oncology trial experience
