**Work Schedule** Standard (Mon\-Fri)**Environmental Conditions** Office**Job Description** According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. * Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. * Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate. * Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clienst, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.* Provides system support (i.e. GoBalto \& eTMF). * Supports RBM activities. * Performs administrative tasks on assigned trials including but not limited to: timely processing of documentssent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members. * Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes. * Reviews and tracks local regulatory documents. * Transmits documents to client and centralized IRB/IEC. * Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. * Maintains vendor trackers. * Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non\-clinical study supplies to sites. * Assists with study\-specific translation materials and translation QC upon request. * May attend Kick off meeting and take notes when required.