Site Start Up EUCTR I

Roles & Responsibilities
EUCTR & CTA Submissions
• Plan and submit Phase I initial submissions under EU CTR
• Manage Mono-national Clinical Trial Application (CTA) submissions
• Handle substantial and non-substantial modifications
• Ensure compliance with country-specific regulatory requirements
CTIS Database Management
• Identify participating EU Member States
• Capture and manage trial data within the CTIS database
• Upload site-level and country-level CTA documents
• Maintain milestone tracking (Study Start, Enrollment, Completion, Holds)
Regulatory & Stakeholder Coordination
• Collaborate with Clinical Trial Management, Regulatory Affairs, and Clinical Transparency teams
• Triage and respond to Requests for Information (RFI)
• Coordinate submission readiness and documentation completeness
IVDR Ethics Submission Support
• Collect IVDR-required documentation
• Ensure compliance with country-specific IVDR regulations
• Support ethics committee submission workflows
Lifecycle Management
• Maintain investigator and institution records
• Archive regulatory documents as per compliance standards
• Monitor Part-II CTA progress aligned with clinical trial timelines

Qualification
• Bachelor of Pharmacy, Master of Pharmacy, Doctor of Pharmacy, Degree in Bsc, Msc and LifeScience

Experience
• 1–2 years of experience in clinical trial start-up
• Experience with EUCTR submissions and CTIS platform
• Experience in regulatory documentation processes

Skills
• Knowledge of ICH-GCP guidelines
• Understanding of EU Clinical Trial Regulation (CTR)
• Familiarity with IVDR regulatory framework
• Experience with CTMS and TMF systems
• Proficiency in MS Excel, Word, and PowerPoint
• Basic project management skills
• Strong interpersonal and stakeholder management abilities
• High attention to detail and compliance orientation

About the Organization
Parexel is a global Contract Research Organization (CRO) providing clinical research, regulatory consulting, and drug development services to pharmaceutical and biotechnology companies worldwide, supporting compliance with international clinical trial regulations.