Are you passionate about advancing healthcare through clinical research? As a sponsor-dedicated CTA, you’ll play a pivotal role in managing and coordinating clinical studies, contributing to groundbreaking medical discoveries.

REQUIREMENTS:

• Bachelor of Science degree preferred or an equivalent scientific or commercial Higher Vocational Education with preferably experience in the healthcare field, pharmaceutical industry or clinical research.
• Fluent in German and English, both written and verbal
• 2–3 years of experience in clinical research
• Familiarity with clinical trial processes, protocol designs, study procedures, and project timelines.
• Knowledge of GCP/ICH Guidelines and applicable regulatory authority requirements.

THIS ROLE IS FOR UPCOMING FUTURE OPPORTUNITIES THAT MAY ARISE AT FORTREA

It offers hybrid model possibility in the Cologne - area (client-office based).

RESPONSIBILITIES:

• Support Global Study Operations: Assist the global study team with delegated tasks, ensuring compliance with GCP, regulatory standards, and sponsor’s internal procedures.
• Coordinate Study Logistics & Communication: Manage study documentation, internal and external communications, training materials, and vendor system access across various platforms.
• Maintain Study Tracking Systems: Oversee and update operational tools (e.g., CTMS, eTMF…), track study progress, and generate reports for study leadership.
• Organize Meetings & Events: Lead logistical coordination for internal and external meetings, including investigator meetings, vendor kick-offs, and training sessions.
• Ensure Documentation Quality: Maintain and audit the Trial Master File (eTMF) for completeness and compliance, supporting regulatory submissions.
• Support Outsourced Studies: Act as a liaison between Medical Affairs, CROs, and internal teams.
• Drive Process Improvement: Contribute to departmental initiatives and special projects aimed at enhancing operational efficiency and quality.