Senior Clinical Study Administrator

Role Overview The Clinical Study Administrator (CSA) supports the coordination of clinical trial activities from start-up to close-out, ensuring adherence to Good Clinical Practices (GCP), SOPs, and regulatory standards within Country Operations Management (COM). They collaborate closely with project managers, study start-up teams, clinical research associates, site management leads, and vendors to facilitate trial execution and documentation management. Key Responsibilities Assist in achieving quality, timely deliverables across trial phases, including site identification, feasibility, start-up, recruitment, data management, and documentation.Manage electronic Trial Master File (eTMF), regulatory documents, training records, and milestone tracking in Clinical Trial Management System (CTMS).Support start-up activities such as contract negotiations, site file preparation, and site activation.Coordinate trial supply logistics and communicate with study sites and vendors.Serve as a central contact for project communications and documentation.Contribute to the development and maintenance of project management tools and support global process standardization.Assist with regulatory submissions, translations, and local study logistics including meetings and onboarding. Qualifications & Skills Minimum 3 years of experience with a Bachelor's Degree.Proficiency in MS Office and understanding of drug development processes.Strong organizational, interpersonal, and communication skills, with attention to detail.Ability to manage competing priorities and work effectively in a remote, collaborative environment.Preferred experience in clinical research and knowledge of rare disease areas.Flexible, team-oriented, and adept at adapting to change and implementing efficient processes. Additional Information The position offers competitive compensation, incentives, and comprehensive benefits including retirement plans, paid time off, and health coverage. It encourages applications from diverse candidates and provides accommodations for individuals with disabilities.