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    Director Clinical Trial Transparency Anonymization - Warsaw, Polska - AstraZeneca

    AstraZeneca
    AstraZeneca Warsaw, Polska

    2 dni temu

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    W pełnym wymiarze godzin
    Opis

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    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-2024

    Closing Date

    24-maj-2024