ResponsibilitiesSupport other CRA team members, acting as RBQM Leads, in the identification and management of protocol, critical data and process, 'Critical to Quality' elements, safety and data integrity, and other protocol execution risks.Support cross-functional study team and RBQM Leads in Protocol Risk Assessment, risk identification and evaluation into Risk MAP, as required.Support RBQM Leads in selection and implementation of Key Risk Indicators (KRIs), Quality Tolerance Limit parameters (QTLs), and other applicable assessments and dashboards for each study in the RBQM system, ensuring consistency with applicable standards.Perform the set up and maintenance of the Risk-Based Quality Management (RBQM) system based on study teams requirements, data sources and structure. Perform peer reviews, QC and/or validation of study setup in RBQM system vs RBQM Plan and system specifications, as required.Work collaboratively with assigned Programmer to implement and refine study-specific KRIs and QTLs in the RBQM system.Execute and review the Study's assessments and analysis, diagnosing and explaining anomalies identified in the data and risks, as required.Deliver timely and high-quality risk-based monitoring analytics and support RBQM leads in communication to the cross-functional study team and CRO (both written report and oral presentation) to identify issue resolution as required.Support RBQM Leads during risk review sessions with cross-functional study team throughout clinical trials lifecycle.Ensure appropriate status and process documentation is produced and maintained during the study, including study-specific validation.Communicate and/or escalate serious risks and issues to the cross-functional study team and/or management and Quality, as needed.Support RBQM Lead in conducting end of trial summarization of risk management activities, including QTL and other issue findings summaries, in preparation for inclusion in the clinical study report.Ensure inspection readiness for clinical risk management and centralized monitoring activities scope of activities.Champion RBQM within the company and participate in continuous improvement and development of risk management processes and systems as needed.QualificationsQualifications Proven experience in a clinical research environment.At least 3 years experience in a pharmaceutical/biologics/biotechnology company.Working knowledge of clinical development processes, understanding concepts and principles of study design, conduct and close out, as well as clinical program development.Skills Familiarity and good understanding of clinical trials risk management concepts and principles in the Pharma or CRO industry.Experience with data analytics and data visualization technologies.Strong critical thinking and analytical skills with an aptitude for data analytics including mathematical and statistical concepts.High degree of accuracy and attention to detail.Experience and understanding of clinical trial data from various sources (e.g., Clinical devices, SDTM, RAVE, IRT, etc.).Ability to work collaboratively in a team environment while managing changing priorities to achieve goals/targets.Ability to build, develop, and maintain good working relationships with internal and external cross-functional customer groups.Excellent English oral and written communication skills.About UsCytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel's scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value, and unlock the full potential of their data.
Come be a part of a team where talent, experience, and scientific rigor come together to advance the state of clinical development. As the industry's largest provider of statistical software and advanced analytics, Cytel is home to some of the most innovative, collaborative, and rigorous biostatistics, statistical programming, and data management talent. Cytel careers offer meaningful work and stimulating challenges within a welcoming and diverse global culture.
Whether your specialty is biostatistics, statistical programming, adaptive clinical trial design, clinical data management, Bayesian statistics, real-world evidence, artificial intelligence, health economics, or a corporate function, you will be growing an exciting career while contributing to advancing the future of human health at Cytel. Search our open jobs or get in touch today to find your fit!
Job InfoJob Identification: 41Job Category: Clinical Data Insights & AnalyticsPosting Date: 12/04/2024, 01:23 PMJob Schedule: Full time
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