Risk Based Monitoring Coordinator/Central Monitor

TheRisk Based Monitoring Coordinator/Central Monitorreports to the Senior Director, Data Insights and Analytics and is responsible for the delivery of timely and high-quality Centralized Monitoring activities, assessments and analytics for their assigned clinical trials in accordance with ICH GCP E6 requirement.Working closely with other CRA team members the Analyst will support the risk assessment and compliance with the protocol, ICH-GCP, and/or all applicable local and federal regulatory requirements to ensure patient safety and data integrity.

TheRisk Based Monitoring Coordinator/Central Monitorwill;

• Support 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
• Supports 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), and 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
• Performs, as required, the execution and review of the Studys assessments and analysis, and diagnosing and explaining anomalies identified in the data and risks
• Deliver timely and high quality risk-based monitoring analytics and supportsRBQM leads in communication to the cross-functional study team and CRO (bothwrittenreport and oralpresentation)to identify issue resolution as required
• Support RBQM Leads during risk reviews 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 to clinical study report.
• Ensure inspection readiness for clinical risk management and centralized monitoring activities scope of activities
• Champion RBQM within the company and participates in continuous improvement and development of risk management processes and system as needed

Qualifications

• Proven experience in a clinical research environment
• At least 3 years experience in a 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 develop

Skills

• Familiarity and good understanding and knowledge of clinical trials risk management concepts and principles in the Pharma or CRO industry
• Experience with data analytics and data visualisation technologies
• Strong critical thinking and analytical skills and aptitude for data analytics including mathematical and statistical concepts
• High degree of accuracyand attention todetail
• 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 whilst 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 Englishoral and written communication skills

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