La 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 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 30,986 - 57,540 Euros. Roche Italy offers a 14-month period salary. The final compensation will be determined by a variety of

📌 Study Start Up Lead (Italia)
🏢 Roche Holding
📍 Italia