Global Study Start-Up Lead

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

Descrizione del lavoro

Novo Nordisk is seeking a Senior Study Start-up Specialist in Italy to drive regulatory submissions and site activations for clinical trials. You will manage end-to-end study start-up, ensuring timely approvals and compliance with local and international regulations.

You will coordinate with internal and externalStakeholders, maintain trial master file, and ensure adherence to Novo Nordisk SOPs while leveraging digital tools to improve efficiency. Fluent Italian and English are required.

Competenze

• 3–5 years in clinical trial study start-up or regulatory submissions.
• Solid knowledge of ICH-GCP and local regulatory requirements.
• Experience with regulatory authority and ethics committee submissions.
• Strong organizational and stakeholder management skills.
• Proficiency in Italian and English.
• University degree in life sciences or related field.

Mansioni

• Manage regulatory authority and ethics committee submissions across projects.
• Coordinate with stakeholders to submit start-up documents through CTIS portal.
• Ensure compliance with ICH-GCP and Novo Nordisk SOPs.
• Contribute to process improvements and share best practices.
• Maintain trial master file documentation and start-up tracking.
• Collaborate with affiliate functions for start-up activities and contracts.
• Partner with clinical trial managers to drive study success.

Conoscenze

Clinical trial start-up experience

Regulatory submissions knowledge

ICH-GCP knowledge

Regulatory submission processes

Multi-project management

Stakeholder management

Digitalisation & AI tools

Life sciences degree

BSc/MSc in life sciences

Formazione

Life sciences / Pharmacy / Nursing degree (BSc/MSc)

Strumenti

CTIS portal

Descrizione del lavoro

Novo Nordisk is seeking a Senior Study Start-up Specialist in Italy to drive regulatory submissions and site activations for clinical trials. You will manage end-to-end study start-up, ensuring timely approvals and compliance with local and international regulations.

You will coordinate with internal and externalStakeholders, maintain trial master file, and ensure adherence to Novo Nordisk SOPs while leveraging digital tools to improve efficiency. Fluent Italian and English are required.