Work Schedule
Other

Environmental Conditions
Office

Job Description

• Coordinates, oversees and completes functions on assigned trial activities detailed on the task matrix.
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. Follows up for resolution of findings and raises whenever vital.
• Ensures allocated tasks are performed on time, within budget and to a high quality standard. Bring ups in cases of variances (overburn/underburn) for self and junior PSCs, reviews and re-distributes the tasks based on junior PSC's free capacity
• Supports the maintenance and oversight of study specific documentation and global support with specific systems, tools and trackers 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, supervising study level documents, maintaining audit readiness and presenting 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 and 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.