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Centralized Trip Report Reviewer-I

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Centralized Trip Report Reviewer-I in Bengaluru-Karnataka new

  • GlaxoSmithkline
  • Full time
  • Email
  • Bengaluru-Karnataka
  • 2024/05/04
  • Report

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 & 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. Labcorp is proud to be an Equal Opportunity Employer: As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status. For more information about how we collect and store your personal data, please see our Privacy Statement.



GlaxoSmithkline

Our?Pharmaceuticals business?has a broad portfolio of innovative and established medicines in respiratory, HIV, immuno-inflammation and oncology. We are strengthening our R&D pipeline through a focus on immunology, human genetics and advanced technologies to help us deliver transformational new medi...

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