Site Start up EUCTR II

Responsibilities

• Plan and submit complex EUCTR submissions for large phase II and III clinical trials across multiple countries and sites
• Implement operational strategic direction and guidance for respective clinical studies
• Build and maintain productive collaborations within study teams
• Manage vendors and ensure effective cross-functional team interaction
• Utilize a data-driven approach to planning, executing, and problem-solving within the study start-up phase

Requirements

• Bachelor’s degree
• 3-4 years of relevant experience in clinical drug development or study start-up
• Strong knowledge of ICH/GCP, EUCTR, and IVDR regulatory guidelines
• Proficiency in Trial Management Systems (CTMS, TMF) and MS Office (Project, PowerPoint, Word, Excel)
• Proven project management, organizational, and vendor management skills
• Excellent interpersonal, leadership, and communication skills (verbal, written, and presentation)
• Ability to meet deadlines through effective prioritization and self-discipline
• Willingness to travel up to 25%

About the Company

Parexel is a global leader in clinical research, dedicated to putting patients at the heart of every clinical trial. With a massive global footprint and a mission to help innovative treatments reach patients faster, Parexel fosters a compassionate, results-driven culture focused on excellence and empathy.