.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.Knowledge, Skills and Abilities:- Ability to work in a team or independently as required- Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively- Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency- Strong customer focus- Flexibility to reprioritize workload to meet changing project timelines- Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout- Good English language and grammar skills and proficient local language skills as needed- Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems- Ability to successfully complete PPD clinical training program- Self-motivated, positive attitude and good interpersonal skillsWorking Environment:PPD values the health and wellbeing of our employees