Global Study Start-Up Lead – Regulatory & Ethics

Novo Nordisk A/S; Roma; In loco; EUR 53.000 - 82.000; Tempo pieno

Vantaggi offerti da questo lavoro

Salary disclosure at offer stage

Incentives and benefits package

Career development opportunities

Descrizione del lavoro

Novo Nordisk A/S in Italy is seeking a Senior Study Start-up Specialist to drive regulatory submissions and site activation for clinical trials, ensuring compliance with ICH-GCP and local requirements. You will manage end-to-end start-up, coordinate with internal and external stakeholders, maintain trial master file, and support contracts and budgets in a fast-paced, global environment.

Joining the Clinical Development Centre (CDC) in Trial Operations EUCAN, you will contribute to timely trial

Competenze

• Experience in regulatory submissions and ethics committee approvals.
• Strong knowledge of ICH-GCP and local regulations.
• Excellent stakeholder management across functions and cultures.
• Proficiency in both Italian and English.
• Experience with trial start-up processes in pharma/biotech.

Mansioni

• Managing regulatory authority and ethics committee submissions across assigned projects.
• Coordinating with stakeholders to collect, review and submit start-up documents through CTIS.
• Ensuring compliance with ICH-GCP and Novo Nordisk SOPs during trial conduct.
• Contributing to process improvements and sharing best practices in start-up teams.
• Maintaining trial master file documentation and start-up tracking systems.
• Collaborating with monitors, CTAs, legal teams to negotiate site contracts and budgets.
• Partnering with clinical trial managers to drive study success and patient impact.

Conoscenze

Regulatory submissions

Ethics committee submissions

Clinical operations

ICH-GCP knowledge

Stakeholder management

Italian language

English language

Digitalisation / AI tools

Startup experience

CTIS portal experience

Formazione

BSc or MSc in life sciences

Strumenti

CTIS portal

Descrizione del lavoro

Novo Nordisk A/S in Italy is seeking a Senior Study Start-up Specialist to drive regulatory submissions and site activation for clinical trials, ensuring compliance with ICH-GCP and local requirements. You will manage end-to-end start-up, coordinate with internal and external stakeholders, maintain trial master file, and support contracts and budgets in a fast-paced, global environment.

Joining the Clinical Development Centre (CDC) in Trial Operations EUCAN, you will contribute to timely trial