Study Start Up Lead
Pubblicato il 01-08-2026 - Biotecnologie - Farmacia - Chimica in Italia
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 factors, including skills,