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    Director Clinical Trial Transparency Anonymization

    Astrazeneca
    7+ years
    Not Disclosed
    Boston
    10 July 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Director Clinical Trial Transparency Anonymization

    At AstraZeneca, we are reshaping our future by thinking and acting differently. We leverage our unique blend of scientific and commercial expertise to identify opportunities and drive impactful outcomes. Our patient-first approach informs every decision, ensuring we meet real patient needs. We encourage innovation, learn from experimentation, and value a collaborative environment where everyone is empowered to share ideas. Join us as part of a global, winning team filled with the brightest minds, and help us break new ground.

    Role Overview:

    As the Director of Clinical Trial Transparency Anonymization, you will be responsible for overseeing the resources, processes, tools, and expertise needed to meet global requirements. This role involves cross-functional collaboration to ensure the production of best-in-class anonymized documents for external sharing.

    Key Responsibilities:

    • Document Delivery: Ensure the delivery of anonymized and redacted documents in compliance with Health Canada PRCI, EMA Policy 0070, and EMA EU CTR post-MAA requirements.
    • Tool Utilization: Implement best-in-class tools for document anonymization and redaction.
    • Patient Reidentification: Expertly measure the patient reidentification threshold on clinical SAS datasets to comply with agency recommendations.
    • Information Practice: Uphold good information practices in all assigned activities.
    • Decision-Making: Make real-time decisions that balance multiple global priorities and stakeholders.
    • Resource Management: Coordinate with global regulatory leaders to set priorities for submissions and manage resources.
    • Team Management: Hire, manage, and develop the anonymization team, assigning workloads to balance company priorities.
    • Guideline Management: Oversee and maintain the Global Redaction Guidelines for clinical documents, ensuring compliance with privacy laws.
    • Report Authorship: Lead the authorship of anonymization reports for Health Canada and EMA Policy 0070 submissions.
    • Training Development: Define and maintain training programs for Document Anonymization Analysts, ensuring effective onboarding and skill development.
    • Process Improvement: Drive productivity and efficiency in the document delivery process.

    Essential Skills/Experience:

    • Anonymization Expertise: Extensive knowledge of clinical document anonymization and patient reidentification thresholds.
    • Clinical SAS Expertise: Proficient in clinical SAS datasets and document management.
    • Management Skills: Experienced in managing teams, with strong interpersonal, coaching, and leadership skills.
    • Business Process Management: Proven experience as a business process owner with strong project management skills.
    • Communication and Collaboration: Advanced verbal and written communication skills, with a collaborative mindset.
    • Problem-Solving: Strong problem-solving and conflict resolution abilities, with attention to detail.
    • AI and Clinical Research: Understanding AI principles and their application in clinical research, along with knowledge of the E2E clinical data lifecycle.
    • Regulatory Expertise: In-depth knowledge of Health Canada PRCI, EMA Policy 0070, and EU CTR post-MAA Transparency regulations.
    • Validated Systems: Experience managing validated systems.
    • Educational Background: MSc in Life Science; background in statistics, engineering, or computer science is preferred.
    • Travel: Willingness to travel domestically and internationally.

    Desirable Skills/Experience:

    • Global Development Knowledge: Understanding of global medicines development.
    • Leadership Experience: Proven leadership in a global organization, with experience in operational excellence and lean principles.
    • Programming and Medical Writing: Knowledge of statistical or database programming languages (preferably SAS) and medical writing experience.
    • User Acceptance Testing: Experience with UAT for validated tools.
    • Regulatory Policy Delivery: Experience in leading regulatory policy delivery.

    Summary:

    AstraZeneca is committed to diversity and equality of opportunity. We strive to build an inclusive and diverse team that represents a wide range of backgrounds and perspectives, believing that inclusivity enhances our work. We welcome applications from all qualified candidates and comply with all applicable laws and regulations on non-discrimination in employment, recruitment, work authorization, and employment eligibility verification.

    Are you ready to fuel your ambition and make a difference? Apply now and join a team that values your insights and passion!

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