Centralized Trip Report Reviewer-I Full-time Job

Management of projects under direction of a Project Manager / Director as assigned. Ensure site monitoring responsibility for clinical studies are conducted according to Standard Operating Procedures, ICH Guidelines and GCP. Work Closely with project teams in implementation of best TRR practices amp; applicable project plans as assigned Implementation of Initiatives either independently or with team Proactively identify opportunities for process improvements and work collaboratively with project team incase further action required Complete required trainings according to required timelines. Follow applicable departmental Standard Operating Procedures and Work Instructions Follow project issue escalation process and Corrective Action Issue Resolution CAIR process for clinical operations issues Ensure follow up on issues and risks and protocol deviations and to be a liaison between CRA, CTL and PM for timely resolution of issues Responsible for the timely and appropriate communication to the clinical operations team Liaise with CTL/PM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety. Review progress of project and initiate appropriate actions to achieve target objectives assigned. Support in review of Standard Operating Procedures or Work Instructions to align with process or tool modifications Other duties as assigned by management: Ex: Document Review, ETMF reconciliation, other CTL tasks etc.

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