Senior Study Start-Up Lead - Global Trials (Italy)

Biopharma Careers; Roma; In loco; EUR 53.000 - 82.000; Tempo pieno

Vantaggi offerti da questo lavoro

Incentives

Benefits designed by market benchmarks

Descrizione del lavoro

Novo Nordisk Italy is seeking a Senior Study Start-up Specialist to enable clinical trials to launch on time and in compliance with local and international regulations. You will manage end-to-end study start-up, navigating regulatory landscapes to ensure sites are activated efficiently and patients access investigational treatments quickly.

You will oversee regulatory authority and ethics submissions, coordinate start-up documents through CTIS portal, ensure ICH-GCP compliance, and collaborate

Competenze

• Minimum 3–5 years' experience in clinical trial start-up or regulatory submissions.
• Solid knowledge of ICH-GCP guidelines and local regulatory requirements.
• Experience with regulatory authority submissions and timelines.
• Strong organizational skills with ability to manage multiple trials.
• Excellent communication and stakeholder management across cultures.
• Proficiency in Italian and English.
• Relevant university degree in life sciences, pharmacy or related field.

Mansioni

• Managing regulatory authority and ethics committee submissions across assigned projects, ensuring timely approvals for clinical trial initiation and conduction
• Coordinating with internal and external stakeholders to collect, review and submit essential start-up documents through CTIS portal
• Ensuring compliance with ICH-GCP guidelines, local regulations and Novo Nordisk SOPs throughout trial conduction
• Contributing to process improvements and sharing best practices across local and global study start-up team
• Maintaining accurate and up-to-date trial master file documentation and start-up tracking systems
• Collaborating with monitors, clinical trial administrators and legal team to negotiate and finalise site contracts and budgets
• Establish partnership with clinical trial managers to drive studies’ success and patient impact

Conoscenze

Clinical operations expertise

ICH-GCP knowledge

Regulatory submissions

Stakeholder management

Project management

Formazione

BSc or MSc life sciences

Descrizione del lavoro

Novo Nordisk Italy is seeking a Senior Study Start-up Specialist to enable clinical trials to launch on time and in compliance with local and international regulations. You will manage end-to-end study start-up, navigating regulatory landscapes to ensure sites are activated efficiently and patients access investigational treatments quickly.

You will oversee regulatory authority and ethics submissions, coordinate start-up documents through CTIS portal, ensure ICH-GCP compliance, and collaborate