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 capacitySupports 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.  

Education and Experience:

High  /  Secondary school diploma/ 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).