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