Central Monitoring Lead

22 hours ago

Bengaluru, India ScaleneWorks Full time

Single point of accountability to embed the application of Risk Based Quality Management aligned with the study planning, study protocols, GSK SOPs, ICH GCP and regulatory requirements for assigned GSK sponsored and outsourced studies.; includes the set up and execution of Central Monitoring and Data Analytics tool. Drive discussions with Global Clinical Operations, Data Strategy and Management, Stats and Programming, Medical and Safety team at CSI for critical to quality measures to prevent study failure. Initiate and lead multifunctional teams on identification of critical data and critical processes that provide robust risk assessment with management planning of appropriate mitigation strategies. Ensure monitoring mitigations to study and data risks are fit for purpose and included in the appropriate operational plans (e.g. Monitoring Plan, Central Monitoring Plan and Data Quality Plan). Influencing skills and critical thinking to planning and execution of a study Accountable for study level data analytics investigations, vendor deliverables and performance. Develop and implement improvements to Central Monitoring and Data Analytics group and recommend tool enhancements to vendor. Assess and implement central monitoring requirements at a study level to ensure consistent approach and oversight to data quality to multiple studies. Interpret impact of analytic signals for study deliver during execution of trial Work with central monitors and study teams to define and agree on remediation to address trends, signals and issues in the data. Subject matter expert (SME) on RBM, CMDA to the central study team and in-country operational staff, such as the Clinical Research Associates (CRAs) / Senior CRAs (SCRAs), Local Study Managers (LSMs)/Senior LSMs (LSSMs) and others aligned to their assigned study(studies). Mentor and train new central monitors, members of the central and local study teams on RBM, Centralized Monitoring processes and applicable RBM Tool(s) using learning principles.

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