Senior Study Start-Up Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/841e02

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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/841e02