Study Start Up Lead

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/77w5pj

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 master’s 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 clinic

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/77w5pj