PPD clinical research services’s mission is to improve health. It
starts as an idea to cure. It becomes a life saved. All in-between,
it’s you! We know that meaningful results not only require the
right approach, but also the right people. We invite you to
re-imagine health promoting protocols with us, working alongside
our talented, bright and energetic teams.
Due to the constant expansion of our global centralized functions in Sofia we’re opening opportunities for professionals within the Project Support Services group in the role of Project Support Coordinator. Intermediate fluency in Italian, German, Spanish, Dutch or French is required.
Office, Flex or Remote work options are available to all candidates, including those outside of Sofia.
As a Project Support Coordinator, you will provide administrative and technical support to project teams including planning, organizing and coordinating responsibilities at a global level with supervision (as required) of the operational activities. You will assist with initial setup, ongoing maintenance of various systems, data entry completion and maintenance of database repositories. The role assists in preparing reports and data collection for analysis. You will also support audit readiness by ensuring files are reviewed on schedule, as detailed in the organization's SOPs/Client specific guidance document. You will support the maintenance of project specific documentation and systems by managing access requests, tracking project level documents and maintaining electronic trial master file audit readiness by conducting regular file reviews.
• 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. Escalates in cases of variances (overburn/underburn).
• 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 (i.e. CTMS, Oracle Activate & eTMF) support by managing the access requests, tracking study level documents and maintaining audit readiness.
• Performs administrative tasks on assigned trials including, but not limited to: timely processing of documents sent to PPD's/Client eTMF as required, performing PPD's/Client eTMF 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 and distribution of related meeting minutes.
• Exports and prepares study metrics reports.
• Maintains vendor trackers.
• Assists with coordination and compilation of Investigator Site File (ISF) template and pharmacy binder, with instruction from the Clinical Team Manager.
• When required attends Kick off and Project Launch meetings and takes notes, supports initial study set-up.