As part of the Data Monitoring and Management group, an integral delivery unit within the Global Biometrics and Data Management (GBDM) organization, the Central Monitor is a highly technical study team member responsible for programmatically applying statistical tests to identify areas of risk in operational and clinical trial data in Pfizer's Risk Based Monitoring (RBM) model.
Activities typically include developing the Risk-Based Monitoring system (i.e. CluePoints) for applicable studies, ensuring key risk indicators (KRIs) and data quality assessment (DQA) properly defined and set up in the system to support the study, processing and reviewing study data in the system for the signal and action management, and follow up for the issue resolution. How You Will Achieve It
System setup Functions:
- Review protocols to ensure the set-up, review and reporting requirements can be met and are standardized.
- Provide technical oversight, guidance and coordination for all the central monitor activities.
- Set up and test RBM- Central Monitoring Analytics system at study level to ensure system quality.
- Define key risk indicators (KRIs) in study system, and ensure consistency between the standard level and the study level.
- Ensure RBM system alignment with the protocol and adherence to ICH GCP, SOPs, corporate standards and regulatory requirements.
Data review Functions:
- Work with Study Team to define the issue resolution for the review of findings as signals and actions.
- Develop, implement, and maintain Quality Control related documentation for RBM related activities to ensure data completeness and accuracy.
- Perform central monitoring activities including review system outputs, propose suggestions for signal and action management, and follow up with study team for the action resolutions.
- Work with Clinical Data Scientist (CDS) to ensure all signals and actions are properly mitigated and RBM systems properly released.
- Ensure lessons learnt during the course of the study are documented and shared with other central monitors/ study teams to facilitate cross-study learning.
- Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
- Provide technical expertise to set up and test study level Risk-based Monitoring system.
- Review study level system outputs to process for the signal and action management.
- Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.
- Able to resolve conflicts, influence and communicate cross-functionally with key stakeholders and customers.
- Bachelor's Degree in a scientific or business related discipline.
- 3+ years' professional experience, ideally in data management/programming or other technical area.
- Demonstrated knowledge of clinical development including knowledge and understanding of the principles of GCP, particularly in relation to risk-based monitoring.
- Understanding of clinical trials.
- Awareness of relevant data standards, e.g. CDISC, CDASH, SDTM.
- Experience with or ability to learn programming in a clinical trial environment, e.g. SAS code, SQL query, R, Python, to extract and analyze operational and clinical trial data from various information systems.
- Ability to critically analyze, interpret, and summarize statistical output from risk-based quality management software, e.g. CluePoints
- Ability to manage tasks, time and priorities.
- Demonstrated effective verbal and written communication skills, including the ability to communicate in a remote team environment and adapt communications to audience.
- Master's degree.
- Relevant pharmaceutical industry experience.
- Experience with or ability to learn data visualization techniques, e.g. Spotfire, JReview, Tableau, PowerBI.
- Proficient experience using commercial clinical data management systems and/or EDC products.
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