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The Clinical Study Administrator will provide support to the clinical study staff within the Clinical R&D COE:
Supports project managers within the assigned clinical studies and is responsible for processing, tracking, and filling of study documents, and management of the Trial Master File within the clinical projects. In addition, administrative support.
Key job activities - Clinical study administrative tasks (70% of the job):
* Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, department guidelines, and work instructions. * Creation/ distribution of regulatory binders & the wet-ink signed documents binder * Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Respond to problems and assists in implementing corrective and preventive actions. * Assist in providing internal communication of important clinical data and events. * supports ongoing use of CTMS. * Assist in tracking of study activities as applicable and documents relating to such activities. * Coordinate with clinical project managers/ leaders and site monitors for site concerns/issues. * Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role). * May be involved in other tasks to support Clinical Operations
Other administrative tasks - 10% of the job:
* study supplies ordering, shipment, tracking and distribution, if needed * assistance with logistics for investigator meetings/ expert panel meetings * assistance with distribution of news letter (create mailing list from CTMS and routing for internal approval) * participates in process improvement activities related to CTMS/v-TMF within the department
* minimum of Bachelor's Degree is required * excellent communication skills in English * experience in clinical study field is required: recent trial master file (TMF) experience * clinical/ medical background or experience is a plus * profound knowledge of MS Office (Excel, Word and PowerPoint) * demonstrated competencies in the following areas are required: tracking, written and verbal communication skills, attention to details, organizational skills