Job Purpose:

To support the implementation of Risk Based Quality Management (RBQM) across studies, focus on Centralized Monitoring (CM) and Data analytics (DA) to ensure consistent application of RBQM principles. 

From study start through to study Data Base Lock, conducts holistic and centralized review of study data according to the study Monitoring Plan, uses data analytical tools to identify emerging and existing risks to critical study processes and data. Enables proactive identification, communication, escalation, and management of risks at the study/country/site level.    

Key Responsibilities:

• Supports the Central Monitoring Lead in the study-specific set-up and ongoing maintenance of the data analytical tool used for centralized monitoring
• Acts as RBQM data analytical tool expert for conducting data risk review and issue management
• Participates in the training of central and local study teams on RBQM and central monitoring processes
• Performs centralized 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
• Shares the responsibility for data quality at the study, country and site levels 

Qualifications:

Basic:

• Bachelor’s degree in a scientific discipline
• 3–5 years of experience in clinical trials or drug development within Pharma, CRO, or ARO
• Strong communication and collaboration skills
• Fluent in English
• Knowledge of ICH GCP guidelines and clinical research policies

Preferred:

• Familiarity with Risk-Based Quality Management processes
• Experience with Risk-Based Monitoring (RBQM) tools and data analytics (e.g., CluePoints, Spotfire)
• Postgraduate degree in a scientific discipline
• Basic knowledge in R or python; experience working with Git, code reviews, branching strategies
• Previous international or above-country work experience

Benefits:

• Career at one of the leading global healthcare companies
• Attractive reward package (competitive salary, annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit
• Possibilities of development within the role and company’s structure
• Life insurance and pension plan
• Open and inclusive environment which is supportive and welcoming of all diversity strands (gender, race, ethnicity, sexuality, disability, or any other characteristic)
• Private medical package with additional preventive healthcare services for employees and their eligible counterparts
• Sports cards (Multisport)
• Personalized learning approach
• Extensive support of work life balance (flexible working solutions including working from home possibilities, health & wellbeing activities)
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits everyday
• Free car and bike parking, locker rooms and showers

Inclusion at GSK: 

As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at [email protected] to discuss your needs.

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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.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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