Central Statistical Monitor
- Warsaw, Poland
Site Name: Warsaw
Posted Date: Sep 28 2020
GlaxoSmithKline is one of the leading global healthcare companies, driven by innovation and scientific developments. Our mission is to improve the quality of life, enabling people to do more, feel better and live longer. We conduct research aimed at improving the quality of life in three basic areas: Pharmaceuticals, Vaccines and Consumer Healthcare. In our activities, we strive to be a responsible partner, building trust-based relations with healthcare system participants, focusing on dialogue and transparent cooperation.
GlaxoSmithKline is one of the leading global healthcare companies, driven by innovation and scientific developments. Our mission is to improve the quality of life, enabling people to do more, feel better and live longer. We conduct research aimed at improving the quality of life in three basic areas: Pharmaceuticals, Vaccines and Consumer Healthcare. In our activities, we strive to be a responsible partner, building trust-based relations with healthcare system participants, focusing on dialogue and transparent cooperation.
We are currently building a Central Monitoring Team with the hub to be based in Poland and looking for several candidates. The Central Statistical Monitor will be responsible for conducting holistic and centralized review of study data according to the study Monitoring Plan, using data analytical tools to identify emerging and existing risks to critical study data and process.
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
Requirements: - Bachelor's Degree or equivalent in a statistical discipline
- A minimum of 1-3 years central statistical monitoring experience in drug development
- 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
- Demonstrates an good understanding of the statistical methodology and graphical techniques used in centralized monitoring
- 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
- Strong computer skills
- Oncology experience would be advantage
Why GSK?
- Career at one of the leading global healthcare companies
- Contract of employment
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagements, holiday benefit)
- Life insurance and pension plan
- Private medical package with additional preventive healthcare services for employees and their and their eligible
- Sports cards (Multisport)
- Possibilities of development within the role and company's structure
- Personalized learning approach (mentoring, online trainings' platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external trainings)
- Extensive support of work life balance (flexible working solutions, short Friday option, health & wellbeing activities)
- Supportive community and integration events
- Modern office with creative rooms, fresh fruits everyday
- Free car and bike parking, locker and showers
*LI-GSK
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