Central Monitor

Job Description

Key Responsibilities

• Performs centralised statistical monitoring of instream study data focused on identification of inconsistent data, unexpected lack of variability, data trends, and unusual data distributions within and across sites.
• Identifies data quality trends indicative of systematic errors and potential study/country/site performance issues.
• Supports the Central Monitoring Lead in the study-specific set-up and ongoing maintenance of the data analytical tool used for centralized statistical monitoring.
• RBM data analytical tool expert for conducting central statistical review.
• Works with Central Monitors to document observations/findings, implications, and actions within the data analytical tools and provides status reports to be shared with study teams.
• Shares the responsibility for data quality at the study, country, and site levels.

Minimum Level of Education:

Bachelors Degree or equivalent in a statistical discipline. This role requires a good understanding of statistical and medical information, and the ability to apply this understanding to the conduct of instream quality risk management.

Minimum Level of Job-Related Experience:

• End-to-end clinical development/statistical experience.
• Understanding of RBM, use of CSM/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 statistical 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 an 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, its 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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Locations: Bengaluru Luxor North Tower

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