Mayra Gonzalez Email and Phone Number

• Coordinates/supports operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring Roche quality and safety standards, regulations, timelines and budget commitments are met.• Performs/coordinates protocol and site level feasibility activities, including evaluation o patient population and final site selection (if applicable).• Provides input into and/or develops study related materials such as Monitoring Plans, Recruitment Plans and Study Newsletters.• Supports/coordinates the negotiation of site budgets within Fair Market Value (FMV) guidelines, budget plans and provides oversight for site payments per contract, as required.• Maintains effective and ongoing communication with CSM; supports communication with local study teams and to sites as required.• Works with global study team and CSM to manage or support the day-to-day activities of the study, including monitoring reports review, problem solving, issue escalation, timely closure of non-productive sites and tracking of safety procedures.• Supports management of country-level Trial Master File (TMF) and reviews for quality (including translations, as applicable).• Is responsible for the co-ordination and oversight of local affiliate study level audit/ inspection audit action plan activities.• Provides feedback to local vendor manager and CSM on CRAs, and local supplier/vendor performance.• Coordinates study or country communication plan.

The Country Study Manager (CSM) provides leadership and regional/local strategic planning and operational delivery of assigned clinical studies through all phases of study management (preparation, study start-up, conduct, close-out), in accordance with Roche quality standards, all applicable regulations, timelines and budget commitments.The Study Start-up Specialist (SSUS) is responsible for all SSU-related activities in the country/region, on assigned studies, overseeing and leading SSU activities in collaboration with other clinical research stakeholders.