Director Clinical Trial Transparency Anonymization
1 miesiąc temu
is a
Typical accountabilities
Ensures delivery of Anonymized and Redacted documents necessary to meet Health Canada PRCI, EMA policy 0070 and EMA EU CTR post MAA requirements Ensure AZ is using best in class tools to deliver Anonymized and Redacted documents. Expert in Measurement of patient reidentification threshold on clinical SAS datasets to ensure threshold recommended by Agencies is not exceeded. Accountable for good Information Practice on all assigned activities Accountable for real time decisions that balance multiple priorities and stakeholders simultaneously to meet global priorities Coordinates with various global regulatory leaders to determine priorities for AZ submissions and manage resources accordingly. Accountable for hiring and line management of all members of this function. Assign workload for delivery across the Anonymization team effectively, balancing AZ priorities. Accountable to manage the Global Redaction Guidelines for AZ R&D clinical documents, ensuring that they are clear and meet privacy laws. Document owners are accountable for applying them in many areas. Own the Anonymization Report authorship for HC and EMA Policy 0070 submissions for each product submission. Define training program for Document Anonymization Analysts. Maintain training resources, ensuring they are up to date and effective in onboarding new team members. Drive productivity and efficiency in our delivery process.Essential requirements
Expert in clinical document anonymization, including patient reidentification threshold measurement on clinical SAS datasets. Expert in clinical SAS datasets and documents. Experienced manager (matrix and/or direct line) with well-developed interpersonal, coaching, influencing and managing skills, Experienced business process owner. Advanced verbal and written communication and collaboration skills. Experienced project manager with proven project based delivery success. Advanced and proven problem solving and conflict resolution. Diligence – attention to detail and ability to manage a programme of concurrent activities. Understanding of AI principles and effective uses within clinical research. Understanding E2E clinical data lifecycle Understands how programming is used to deliver technical programming and information components of a study, including but not limited to the following:Study Data Tabulation Model (SDTM) and Analysis Data Model (Adam) data setsTables Figures and Listings (TFLs)Clinical Trial Transparency deliverables (results posting, External Data Sharing) Expert in Health Canada PRCI, EMA Policy 0070 and EU CTR post MAA Transparency regulations. Experience in managing validated systems. MSc in Life Science, nice to have statistics, engineering, computer science education, Travel – willingness and ability to travel domestically & internationally.Desirable
Knowledge of global medicines development. Experience leader in global organization. Experience of Operational Excellence, lean principles, processes, tools, behaviours & leadership Prior relevant knowledge of a statistical or database programming language (preferably SAS), development of Tables Figures and Listings Clinical Study Reports Medical writing experience, User Acceptance Testing experience for validated tools Experience in leading delivery to regulatory policies.Date Posted
25-kwi-2024Closing Date
24-maj-2024Mamy inne aktualne oferty pracy związane z tym obszarem, które można znaleźć poniżej
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