Job description

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