Site Name: Bengaluru Luxor North Tower
Posted Date: Feb 22 2023
- End-to-end clinical development/operations experience;
- 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 3-5 years drug development experience in Pharma, relevant CRO and/or ARO
- Understanding of various local regulatory environments
- Previous international/above country work preferred but not mandatory
- Understanding and compliance with ICH GCP, and applicable GSK Pharma R&D policies and SOPs.
- Understanding of RBM, use of data analytics (e.g. Spotfire RBM Tool) and Risk Based Quality Management (RBQM)
- Strong knowledge/experience in project management and matrix team interactions
- Strong communication/negotiation/facilitation/influencing/coaching skills
- Oncology experience would be advantageSupports the Central Monitoring Lead in the study-specific set-up and ongoing maintenance of the data analytical tool used for centralized monitoring
- RBM 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
- Understanding of RBQM, RBM and CM demonstrates a current, in-depth understanding of ICH E6R2 revisions and how determining monitoring approaches, including centralized monitoring is important for delivery of accelerated quality clinical trials
- Demonstrates understanding and importance of risk management and data driven decision making to improve the effectiveness and efficiency of E2E quality clinical trial monitoring to support GSK study delivery strategy.
- Given the interactions with multi-disciplinary teams proven experience in project management, trial execution and delivery, are essential.
Apply : https://jobs.gsk.com/en-gb/jobs/362322?lang=en-us&previousLocale=en-GB
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