Study Start Up Lead

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

As a key member of the Country Study Start-Up Team you will drive and accelerate efficient compliant clinical trial initiation. You will lead country-level strategies cross-functional collaboration and process innovations to ensure seamless trial delivery for patients investigators and global study teams.

Key Responsibilities

• Strategy & Execution: Lead country study start-up strategies mitigate risks and ensure timely site activation in alignment with global goals;
• Submissions & Regulatory Coordination: Oversee clinical trial submissions and amendments; manage regulatory queries and maintain compliance (ICH-GCP EU CTR);
• Documentation & Material Compliance: Manage site documentation local vendor coordination and the translation/approval of patient-facing materials;
• Budget & Contract Management: Oversee site budgets (FMV-based) negotiate contracts (CDAs indemnity/insurance) and maintain accurate forecasting data;
• Innovation & Collaboration: Identify process automation opportunities harmonize systems with global counterparts and engage with external bodies (Ethics Boards Health Authorities).

Qualifications & Experience

• Education: Degree in Life Sciences or equivalent. Postgraduate degree or masters degree highly desirable;
• Experience: Proven track record (3-4 years) in clinical trial start-up regulatory submissions and CRO/vendor management;
• Regulations: Strong knowledge of ICH-GCP EU CTR IVDR/MDR and local regulatory environments.

Core Skills

• Proficiency in clinical systems (Veeva Vault CTIS RIM etc.);
• Strong communication analytical and problem-solving skills;
• Ability to lead through ambiguity within global matrixed teams;
• Fluency in Italian and English (written and spoken) is mandatory.

Location: Monza

Contract offered: Fixed-Term

The expected salary range for this position is 30986 - 57540 Euros. Roche Italy offers a 14-month period salary. The final compensation will be determined by a variety of factors including skills experience and qualifications.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.