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Centralized Monitoring
3 months ago
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.
Area of Specialisation
Clinical trial experience (minimum 1-3 years).
RBM experience (minimum 1 years)
Knowledge of the principles of quality, safety, risk management and compliance (ICH and GCP).
Minimum Level of Job-Related Experience
End-to-end clinical development experience;
Understanding of RBM, use of Data Analytics and Risk Based Quality Management (RBQM) and their impact on data integrity
Business acumen demonstrated by understanding of risk management, problem-solving, the implications of decisions and uses this knowledge to plan and manage issues, projects and processes
A minimum of 1-3 years central monitoring experience in drug development
Understanding of various local regulatory environments
Understanding and compliance with ICH GCP, and applicable GSK Pharma R&D policies and SOPs.
Strong communication/influencing skills Oncology experience would be advantage
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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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
