Senior Study Start-Up Specialist

Novo Nordisk Pharma; Latina; In loco; EUR 53.000 - 82.000; Tempo pieno

Vantaggi offerti da questo lavoro

Incentives and benefits

Global healthcare company environment

Collaborative culture

Impact on patient access

Descrizione del lavoro

Novo Nordisk Pharma seeks a qualified professional to drive study start-up processes, enabling timely trial initiation. You will handle regulatory submissions, coordinate cross-functional teams, and ensure ICH-GCP compliance across projects withinItaly.

The role emphasizes collaboration with local Italian teams, quality documentation, and stakeholder management to accelerate patient access to investigational therapies in a global portfolio.

Competenze

• 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 submissions and timelines.
• Proficiency in Italian and English.
• Applications from other locations in Italy considered.

Mansioni

• 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.

Conoscenze

Regulatory submissions

Stakeholder management

Cross-cultural collaboration

ICH-GCP knowledge

Project coordination

Formazione

BSc or MSc in Life Sciences/Pharmacy/Nursing

Strumenti

CTIS portal

Descrizione del lavoro

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.

• Salary range 53,180.00 to 82,430.00 EUR
• Incentives and benefits
• Global healthcare company environment
• Collaborative culture
• Opportunity to impact patient access to therapies
• 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
• 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
• Proactive problem-solving
• CTIS portal submissions
• ICH-GCP compliance