Country: United Kingdom
Specific Location: Maidenhead
Job Title: Clinical Data Risk Analyst
Type of Job: Permanent
Job Number: 210875
Work Category: hybrid
The Clinical Data Risk Analyst (CDRA) is responsible for the delivery of timely and high quality risk-based monitoring analytics supporting the activities of our clinical trials. Working closely with the Clinical Risk Manager (CRM) the CDRA 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.
Summary of Key Responsibilities
The Clinical Data Risk Analyst (CDRA) will;
• Review and understand the clinical protocol to identify critical data and processes, safety and data integrity risks related to protocol execution.
• Support cross-functional stud team and CRM in Protocol Risk Assessment,risk identification and evaluation, as required
• Support development and documentation of Integrated Risk Management Plan (iRMP)
• Perform the set up and maintainenance of the Risk-Based Quality Management (RBQM) system based on study teams requirements, data sources and structure, in collaboration with the CRM
• Perform peer reviews of study setup in RBQM software, as required
• Lead the implementation of the tailored Key Risk Indicators (KRIs) and Quality Tolerance Limit parameters (QTLs) specifications for each study in the RBQM system, ensuring consistency with applicable standards
• Work collaboratively with assigned Programmer to implement and refine study-specific KRIs and QTLs in the RBQM system
• Perform regular KRI, QTL and Data Quality (DQA) analyses in RBQM system, diagnosing and explaining anomalies identified in the study data
• Deliver timely and high quality risk-based monitoring analytics and supports CRM in communication to the cross-functional study team and CRO (both written report and oral presentation) to identify issue resolution as required
• Support CRM 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
• Provide consultation and related operational support to study teams as needed, with the help of CRM, as needed
• Support CRM 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 clinical data risk analysis scope of activities
• Champion RBQM within the company and participates in continuous improvement and development of risk management processes and system as needed
• Proven experience in a in a pharmaceutical/biologics/biotechnology company
• BS/BA preferably in a scientific or technical discipline
• Thorough knowledge of Good Clinical Practice/ICH E6 (R2+) Guidelines and/or other applicable regulatory requirements for the conduct of clinical trials, with specific focus on updates about Risk Based Quality Management
• 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 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 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 English oral and written communication skills
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.
Closing Date: June 30, 2022
Website/URL for further details: click here