Senior Study Start-Up Specialist
Pubblicato il 21-09-2026 - Novo Nordisk Pharma in Lazio
Overview
In this role, you drive the study start-up process to enable timely, compliant trial initiation.
You manage regulatory and ethics submissions and coordinate cross-functional colleagues to activate sites and enable patient access to investigational therapies.
You will operate within a global trial portfolio, supporting continuous improvement and robust trial documentation.
You will work closely with local teams in Italy to ensure quality, speed, and regulatory adherence.
This is an opportunity to shape early-phase trial readiness and impact patient outcomes.
Retribuzione / Benefits
Salary range 53,****** to 82,****** EUR
Incentives and benefits
Career development opportunities
Global healthcare company environment
Collaborative culture
Opportunity to impact patient access to therapies
Responsabilità
Manage regulatory authority and ethics committee submissions across projects to obtain timely approvals
Coordinate with internal and external stakeholders to collect, review and submit start-up documents through the CTIS portal
Ensure compliance with ICH-GCP, local regulations, and Novo Nordisk SOPs throughout trial conduction
Contribute to process improvements and share best practices across local and global start-up teams
Maintain accurate trial master file documentation and start-up tracking systems
Collaborate with monitors, clinical trial administrators, and legal teams to negotiate and finalize site contracts and budgets
Establish partnerships with clinical trial managers to drive study success and patient impact
Support cross-cultural collaboration and efficient start-up activities across affiliates
Requisiti fondamentali
3–5 years' experience in clinical trial start-up, regulatory submissions or clinical operations in pharma/biotech
Solid knowledge of ICH-GCP and local regulatory requirements
Experience with regulatory authority and ethics committee submissions and timelines
Strong organizational skills to manage multiple trials with attention to detail
Excellent communication and stakeholder management across cultures and functions
Proactive mindset toward digitalisation and AI/digital tools to improve daily work
Bachelor in Life Sciences, Pharmacy, Nursing or related field (BSc or MSc)
Proficiency in Italian and English
Applications from other locations in Italy considered
Cross-cultural collaboration
Proactive problem-solving
Attention to detail
CTIS portal submissions
ICH-GCP compliance
Trial master file management