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Prin Project Support Coord

Pharmaceutical Product Development (PPD)

Bangalore, Karnataka, India

Job Description

· 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 proposes resolution 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. · Contributes to any improvements/enhancements with current processes, tools and systems, whenever applicable. · 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. · Actively participates in client calls by providing updates and proposing solutions · Exports and reconciles study metrics report, if required analyses 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. Hig h/ Se c onda r y sc hool d ip lom a or eq uiv a le nt a nd re le v a nt f orma l a c adem i c/ v o c at iona l q ua li f ic at ion T e c hnic a l p osit ion s ma y re q uire a c e rt if i c at e P re v ious e x pe rie nc e t ha t p rov ide s t he k now ledge, sk ill s, a nd ab ilit ie s t o pe rf o rm t h e j ob( c ompa rab le t o a t lea st 6 y ea rs).

Job posted: 2023-05-30

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