Central Monitor-3

2 weeks ago

Bengaluru Karnataka, India GSK Full time

**Site Name**: Bengaluru Luxor North Tower

**Posted Date**: May 17 2024
**Key Responsibilities**
- Supports the CML in the study-specific set-up and ongoing maintenance of the data analytical tool used for centralized monitoring
- RbQM data analytical tool expert for conducting data risk review, risk and issue management
- Participates in the training of central and local study teams on RbQM and central monitoring processes
- Performs centralised monitoring of study data and maintains oversight of study/country/site risk parameters according to the study monitoring plan
- Identifies data quality trends indicative of systematic errors and potential study/country/site performance issues
- Communicates to relevant study team members trends/findings, implications and recommends actions within data analytical tool and provides regular status reports to study team
- Ensures the proper documentation & archiving of instream data reviews, risk and issue management
- Shares the responsibility for data quality at the study, country and site levels

**Area of Specialisation**
- Clinical trial experience (minimum 1-3 years).
- RbQM 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 RbQM, 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
- SAS & CluePoints 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.

**Important notice to Employment businesses/ Agencies**

**GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.

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