.Clin Ops Delivery Associate ISummarized Purpose:Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document.Essential Functions:- 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.- Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans 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 documents sent 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 of client and/or internal meetings.- 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