Project Support Coordinator

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. P ro v i de s s y s te m ( i. e . C T M S , O r a c le A c t i v at e & e T MF) s u pp ort b y m a n ag ing t he a cc e ss r eq u e s t s, supervising s t u d y l e v e l d o c u me n t s, ma i n t a ining a u d it r ead in e s s a nd presenting t he n o n - c o mp li a n c e t o t he s t u d y tea m and suggesting resolution . Pe r f or m s adm inis t r at i v e ta s k s on a ssi g n e d t ri a ls i n c l u d i n g , b ut not li m i te d t o: t i me ly p ro c e ss i ng o f d o c u m e n t s s e nt t o CR G ' s /C li e nt e T MF as required, pe r f or m ing C R G ' s /C li e nt e T MF r e v i ew s a nd c oo r d in at i n g and proposing is s ue r e so l u t io n , pe r f or m ing ma s s ma ilin g s a nd c o m m un i c at ions a s n e e ded , p ro v i d i ng d o c u me n t s a nd r ep or t s t o in te r n a l tea m membe rs. Su pp or t s s c h ed ul i ng a nd o r ga niz at ion o f c li e nt a nd / or i n te rn a l meet in g s w i t h c o mp l et ion a nd d is t ri b u t i on of r e l ate d meet ing m i n u te s and follow up for closure of action items, if required. E x p or t s a nd r e c o n c il e s s t u d y met ri c s r ep or t s, 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. Ed u c at ion a nd E x pe ri e n c e : Hi g h / S e c on da r y s c hool d i p lo m a/ eq ui v a l e nt a nd r e l e v a nt f or ma l a c adem i c / v o c at ion a l q u a l i f i c at ion T e c hni c a l p osi t io n s ma y r e q uire a c e r t i f i c at e P r e v ious e x pe ri e n c e t h a t p ro v i de s t he k no w l edge , s k il l s , a nd ab ili t i e s t o pe r f o rm t h e j ob ( c o mpa r ab le t o a t l ea st 0 to 4 y ea rs ) .