Site Start Up EUCTR II

Key Responsibilities

• Collaborate with Clinical Trial Management functional representatives to determine key study milestones and country allocation strategies
• Engage with Regulatory Affairs functional representatives to plan the Part II Clinical Trial Application (CTA) for EU countries
• Identify participating Member States and countries within the CTIS database and capture comprehensive study information
• Collect and upload applicable documents at the Member State and site level into the CTIS database for CTA submissions
• Coordinate with Clinical Transparency regarding document redactions required for CTA submissions
• Monitor and report on Part II activity progress to ensure alignment with overall trial timelines and objectives
• Ensure Part II CTA submissions comply with national regulatory requirements in each Member State
• Triage and manage Requests for Information (RFI) from regulatory authorities, coordinating responses with relevant stakeholders
• Collect required documents for IVDR (In Vitro Diagnostic Regulation) ethics submissions and ensure compliance with country requirements
• Maintain comprehensive trial documentation archives in compliance with regulatory requirements and company policies
• Identify and capture key study milestones including Study Start, Study Completion, Enrollment Start, Enrollment Completion, and hold/restart/cancel dates within CTIS

You'll thrive in this role if you bring

Required Qualifications

• Bachelor's degree with 3-5 years of relevant experience in clinical drug development, including study start-up activities
• Strong expertise in ICH-GCP, EUCTR, and IVDR regulatory guidelines
• Experience with trial management systems (CTMS) and electronic Trial Master File (eTMF) systems
• Experience with the Clinical Trial Information System (CTIS) or similar EU regulatory databases
• Experience with IVDR (In Vitro Diagnostic Regulation) submission processes