Clinical Trial Administrator

1 giorno fa

roma, Italia Novo Nordisk Pharma Tempo pieno
Overview

In this role, you support the local study team in Italy from start-up to close-out, ensuring trial documentation, tracking, vendor coordination, and timely investigator payments. You help keep trials compliant and inspection-ready to progress new treatments for patients with serious chronic diseases. Based in Rome, you join the Clinical Development Centre to enable precise, compliant trial execution and cross-functional collaboration. You will leverage digital tools to optimize study operations and accelerate delivery while upscaling skills in AI and technology.

Retribuzione / Benefits
  • salary range 36,640.00–53,130.00 EUR
  • incentives and other benefits depending on level and location
  • career development opportunities
  • upskilling in AI and technology
  • empowerment within a collaborative CDC team
  • 100+ years of company history in improving patient lives
Responsabilità
  • Prepare and submit trial start-up documentation
  • Set up and maintain the electronic Trial Master File (eTMF) and Investigator Trial Master File (iTMF)
  • Track trial activities and coordinate study tasks to support high-quality delivery and inspection readiness
  • Build and maintain relationships with internal and external stakeholders for vendor management
  • Manage site payments, monitor timelines, and resolve payment issues
  • Collaborate with cross-functional teams to ensure smooth information flow and on-schedule trial execution
  • Support ongoing regulatory compliance with study protocols and regulatory requirements
  • Oversee documentation completeness, accuracy, and regulatory alignment
Requisiti fondamentali
  • Master’s degree in Life Sciences
  • Solid understanding of clinical trial phases, regulatory guidelines, GCP, and ethical considerations
  • Hands-on experience with Clinical Trial Management Systems (CTMS)
  • Ability to manage multiple tasks, timelines, and stakeholders
  • Strong written and verbal communication skills
  • Analytical and problem-solving abilities
  • Integrity, sound judgement, and attention to detail
  • Openness to new digital tools and adaptable in a fast-paced trial environment
  • Attention to detail
  • Organisational skills under pressure
  • Strong communication and relationship-building
  • Clinical Trial Management Systems (CTMS)
  • Electronic Trial Master File (eTMF) setup and maintenance
  • Investigator Trial Master File (iTMF) management