Study Start Up Lead

Job description

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 PositionAs 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, experience, and qualifications. Who we areA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.