Position
Country Study Start‑Up Team Member
Key Responsibilities
- Lead country study start‑up strategies, mitigate risks, and ensure timely site activation in alignment with global goals.
- Oversee clinical trial submissions and amendments; manage regulatory queries and maintain compliance with ICH‑GCP, EU CTR.
- Manage site documentation, local vendor coordination and the translation/approval of patient‑facing materials.
- Oversee site budgets (FMV‑based), negotiate contracts (CDAs, indemnity/insurance), and maintain accurate forecasting data.
- 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 or master’s degree highly desirable.
- Experience: 3-4 years in clinical trial start‑up, regulatory submissions, and CRO/vendor management.




- Regulatory knowledge: 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.
- Language: Fluency in Italian and English (written and spoken) is mandatory.

Location
Monza, Italy
Contract Type
Fixed‑Term; 14‑month period salary
Salary
Expected salary range: 30,986 - 57,540 Euros
Benefits
Roche Italy offers a 14‑month period salary. Final compensation will be determined by factors including skills, experience and qualifications.
Equal Opportunity Employer
Roche is an Equal Opportunity Employer.
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📌 Study Start Up Lead (Italia)
🏢 F. Hoffmann-La Roche
📍 Italia