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

Education / Qualifications

Preferred Experience

Additional Information

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.

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