Clinical Site Manager

Overview Clinical Site Manager (CSM II) based in Madrid, Spain. You will serve as the primary contact point between the Sponsor and the Investigational Site, assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company SOPs, Good Clinical Practice (GCP), and applicable regulations from study start-up to site closure. You will manage the site / sponsor relationship as it relates to clinical trial delivery through consistent communication and support. You will collaborate with the Clinical Trial Lead (CTL), Clinical Trial Manager (CTM), Clinical Trial Specialist (CTS), and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial-related activities for assigned protocols. This position reports to the Head, Late-Stage Site Monitoring and is part of the Clinical Operations, Development team. This role is based in Madrid, Spain. It includes a hybrid working model with some travel, per business needs. At Astellas we pursue patient centricity as a guiding principle, combining established company capabilities with startup-like agility to accelerate product development and improve patient outcomes. The role is eligible for hybrid working arrangements in accordance with Astellas’ Responsible Flexibility Guidelines. Responsibilities Act as the primary local company contact for assigned sites for specific trials, including both early and late-phase studies. Drive activities during site initiation and start-up, conduct site monitoring (including remote monitoring), site management (via study-specific systems and dashboards), and site / study close-out in line with SOPs, Work Instructions (WIs), and policies. Implement risk-based monitoring approaches at the site level and work with the site to resolve issues found during monitoring visits. Ensure source documentation and site documentation are adequate and compliant with ALCOA-CCEA, and that site compliance aligns with the study protocol, ICH-GCP, and local regulations. Manage up to 10 sites across 2–4 protocols (depending on complexity) and manage own travel budget within Astellas T&E guidelines. Essential Knowledge & Experience Extensive site monitoring and / or site management experience. Experience in early development studies within Oncology. Strong working knowledge of GCP, local laws and regulations, protocols, and protocol-specific procedures including monitoring guidelines. Strong IT skills in appropriate software and company systems. Proficient in speaking and writing English; fluent in Spanish(local language). Education / Qualifications BA / BS degree in life science or equivalent. Preferred Experience Experience in leading the Lead CSM role. Cross-functional and matrix-team collaboration experience. Mentored junior site monitors and site managers. Additional Information Willingness to travel up to 40% with overnight stays. This is a permanent full-time position based in Madrid, Spain. Hybrid working model; minimum 1 day perquarter in the local office. Flexible as per business needs. Candidate must be located within a reasonable commuting distance of the office. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #J-18808-Ljbffr