Project Support Coordinator

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Project Support Coordinator – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to independently provide administrative and technical support to project teams, including planning, organizing, and coordinating responsibilities at a global level. As a Senior Project Support Coordinator, you'll drive and coordinate the initial study setup, ongoing maintenance of various systems, complete data entry, and maintain database repositories. You will prepare reports, collect data for analysis and reviews, and support audit readiness by ensuring files are reviewed on schedule, as detailed in the organization's SOPs/Client specific guidance document. You will contribute to the risk management process by timely identification and escalation of issues. Acting as a buddy during the onboarding phase, you will provide training to new staff as needed. You will support functional group and cross-functional initiatives for process improvements and enhancements. You may act as a main point of contact with the Project Lead (PL) or Clinical Team Manager (CTM) and provide oversight and coordination support to junior PSCs whenever required. What You’ll Do: • 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. Follows up for resolution of findings and escalates whenever necessary. • Ensures allocated tasks are performed on time, within budget and to a high quality standard. Escalates in cases of variances (overburn/underburn) for self and junior PSCs, reviews and re-distributes the tasks based on junior PSCs' free capacity (in case involved in a Lead role). • Supports the maintenance and oversight 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/clients, 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, maintaining audit readiness, communicating the non-compliance to the study team and suggesting resolution. • Performs administrative tasks on assigned trials including, but not limited to: timely processing of documents sent to CRG's/Client eTMF as required, performing CRG's/Client eTMF reviews, coordinating and proposing issue resolution, 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 and follow up for closure of action items, if required. • Exports and reconciles study metrics reports, and if required analyzes and identifies issues (if involved in a Lead role). • Maintains and regularly checks for correctness of vendor trackers. • Drives and coordinates the compilation of Investigator Site File (ISF) template, pharmacy binder with instruction from the Clinical Team Manager. • Attends Kick off and Project Launch meetings and takes notes when required, supports initial study set-up.

Requirements: • High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Technical positions may require a certificate • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years). In