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. - Ensures allocated tasks are performed on time, within budget and to a high quality standard. Escalates in cases of variances (overburn/underburn). - Supports the maintenance of study specific documentation and systems including, but not limited to: study team lists, tracking of project specific training requirements, system access management, 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 and maintaining audit readiness. - 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 for 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. - Exports and prepare study metrics reports. - Maintain vendor trackers. - Assists with coordination and compilation of Investigator Site File (ISF) template and pharmacy binder, with instruction from the Clinical Team Manager. - When required attends Kick off and Project Launch meetings and takes notes, 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 0 t o 1 y ea r).

2023-05-09

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