10 ott
|
Novo Nordisk Pharma
|
Roma
10 ott
Novo Nordisk Pharma
Roma
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
📌 Clinical Trial Administrator (Roma)
🏢 Novo Nordisk Pharma
📍 Roma