Responsible to provide administrative support for the Project Management group and to lead the study review activities and communications on allocated projects To comply & adhere to GCP guidelines and regulations as required of this role Main Tasks and Responsibilities Assist in the preparation and formatting of study documentation, including informed consent forms, source documents, and client deliverables. Establish and maintain study files, including Trial Master Files (TMF) in both electronic and paper formats. Maintain delegation logs by coordinating with internal teams to ensure accuracy and timely updates for new and terminated staff. Maintain training logs and ensure training compliance for all personnel listed on delegation logs. Manage file note control, including creation, review, and filing. Ensure all regulatory documentation is audit-ready and compliant with archiving requirements. Support study review board submissions by uploading administrative documents, study updates, and required correspondence. Process Spanish regulatory documents and communicate approvals to the screening team. Notify staff of updated or newly released documents via secure file systems. Support the Project Management team with PSA activities, revenue forecasting, and invoicing. Assist with study closeout activities, including budget reconciliation and archiving. Maintain and perform quality control (QC) of the volunteer clinical RSVP database. Manage laboratory requisitions and collaborate with Data Management to support query resolution. Support e. Source User Acceptance Testing (UAT) activities. Assist with the hosting and support of sponsor monitors during site visits and with related action items Job Demands The job may involve the following: Very high concentration of work Strict and tight deadlines Having to juggle a range of tasks/issues simultaneously Working in a hazardous environment with high requirement to follow safety procedures Working outside normal working hours Needing to respond to client demands The Candidate Minimum Degree qualification or equivalent Relevant work experience in a pharmaceutical company/ CRO would be an advantage Computer literate, proficient in Microsoft Windows Proficient in Information Technology Highly organized and efficient Ability to communicate effectively; people-oriented personality