Central Monitoring Lead

Key Responsibilities::

• 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 70-20-10 learning principles.

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Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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