Assist in preparing, maintaining, and updating the Trial Master File (TMF/eTMF). Support with preparation, submission, and tracking of regulatory and ethics committee documents. Ensure proper filing, version control, and archival of essential study documents. Assist Project Managers and CRAs with…
Serve as senior biostatistician for programs of studies, submissions, or on simple to complex individual studies . Oversee statistical activities that support Eccentric interactions with clients and regulatory agencies Review and approve statistical methods sections of study protocols, statistical analysis…
Overseeing the management of clinical trials across the site to ensure they progress in accordance with contract terms and defined quality standards, protocols, SOPs, GCP, and relevant guidelines to meet local regulations. Communicating project scope, timelines, goals, technical details, and…