StudyStartUpSpecialist

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 Position # **Purpose, Objectives and Scope of Position** As a member of the PDG Country Study Start Up Team, your primary focus is to drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials to patients. You will enable innovative clinical trial delivery, address study start up needs across various therapeutic areas, and ensure seamless trial execution for patients, investigators, and clinical site staff. Collaboration with local country teams, global study teams, and CROs is essential to this role. # **Key Responsibilities** This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by executing effective start-up strategies while maintaining regulatory compliance. Additionally, this role involves managing amendments throughout the study lifecycle. You will bring subject matter expertise and may work cross functionally in the following areas below: # **Study Start Up Strategy & Execution:** Support and execute study start-up strategies for faster site activations, collaborating with internal and external teams, CROs, and sites. Help identify issues, follow regulations/SOPs, and assist with Health Authority/Ethics Committee communication. Track submissions in relevant systems and stay updated on regulatory requirements. # **Informed Consent Form (ICF) Management:** Assist in preparing/adapting ICFs, supporting IRB/EC/HA submissions and changes, and archiving approvals. # **Clinical Trial Submissions & Regulatory Coordin