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About the role
- Associate Director of Clinical Data Management Reporting leading clinical data programming and reporting for a biotech company. Managing teams and ensuring data quality while meeting study milestones.
Responsibilities
- Provide strategic leadership for clinical and external data reporting across clinical development unit (CDU) programs.
- Focus on the creation, standardization, and delivery of clinical data programming, external data reconciliation, and reporting deliverables across portfolio.
- Ensure alignment with study data review plans (DRP), study milestone needs, operational metrics, and regulatory requirements.
- Accountable for the oversight and execution of all data management programming deliverables at the portfolio level.
- Responsibilities include quality and timely delivery of programming outputs such as data review plan listings, exception listings, external data reconciliation reports, operational metrics, and other reports supporting clinical trial quality and risk management.
- Manage internal teams and external vendors, ensuring study milestones are met while safeguarding data quality, integrity, and compliance with global regulatory standards.
- Emphasize cross-functional collaboration and deep expertise in clinical data programming, external data handling and reconciliation, industry standards, programming methodologies, and clinical data management systems.
Requirements
- BS/MS
- 10+ years of clinical data management experience in a pharmaceutical or biotech
- 5+ years of people management, leadership, and mentoring experience.
- Demonstrated ability to oversee the development, validation, and delivery of clinical data management programming and visualization outputs to cross-functional teams across drug development programs.
- Experience in transforming raw clinical data, external data handling, processing, validation, and reconciliation outputs into actionable insights to ensure data accuracy and quality in compliance with industry standards.
- Demonstrated ability to function as a clinical data management programming and reporting SME in solving complex issues and guiding internal teams and external vendors for successful outcomes.
- Demonstrated ability to build relationships and collaborate across diverse business units including Clinical Data Management, Clinical Development, Precision Medicine, Imaging, and GDIT.
- Expertise in managing and reconciling clinical eCRF and external data types including PK, ADA, Biomarker, Imaging, ECG, etc., to ensure data accuracy, integrity, and regulatory compliance.
- Proven experience in clinical data operations, clinical data management, reporting, and analytics within a pharmaceutical, biotech, or clinical research organization.
- Knowledge of clinical data management principles, technologies, data extraction, transformation, and integration, programming methods and techniques, regulations and best practices, including 21 CFR Part 11, ICH-GCP, and CDISC standards -- related to data acquisition, processing, handling, and reporting.
- Knowledge and expertise in industry standard reporting and data visualization tools including SAS, R, JReview, Spotfire, Tableau, Power BI, and R Shiny to drive operational excellence for clinical data management reporting.
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
Job title
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