Senior Clinical Study Administrator

Senior Clinical Study Administrator (CSA) assists in coordinating study activities from start-up through execution and close-out within Country Operations Management (COM) to ensure quality, timeliness, and compliance with Good Clinical Practices (GCP), Alexion SOPs, and regulatory requirements. Collaborates with PMCO, CRAs, SSU manager, SML, and HCO to support trial conduct, including site identification, feasibility, startup, recruitment, data deliverables, and eTMF setup and maintenance. Provides regulatory document tracking, training documentation, milestone management in CTMS, and general trial support; supports startup activities (CDA delivery, contract negotiation, site activation) and distribution/collection of documents. Coordinates with vendors and sites on trial supplies and maintains tracking. Serves as central point of contact for communications and documentation; contributes to development/maintenance of project management tools (CTMS, smartsheets). Assists with local translations, IRB/CEC/CA submissions, and local meetings and onboarding. Depending on the country/region, may provide varying levels of COM support. Demonstrates strong collaboration, organization, and communication skills, and ability to work in a remote/matrix environment with attention to efficiency and quality in clinical trials.