Principal/Sr Clinical Data Scientist
1 month ago
The Senior Principal Clinical Data Scientist is responsible and accountable for managing all Data Management deliverables at a consistently high standard with respect to cost, quality and timelines for all assigned indications within one or more Global Clinical Program(s)/Project(s). Ensure consistently high quality data (in alignment with the Novartis Clinical Data Quality Statement) available for analysis and reporting.
Demonstrates a business understanding of the compound profile and data strategy to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i.e., ensuring consistency across data quality plans.
Ensures alignment with the TA level data strategy as defined by the TA Data Strategy Director. Proficient in relevant CDISC or other recognized industry standards and how these impact the programming team. Ensures the key study risks & issues are shared in the Project Review Meeting led by Sr GHs/GHs. Recognize and resolve protocol issues that may impact database design, data validation, program standards and/or analysis/reporting, minimizes the data footprint to focus on the trial endpoints.
Reviews the Data Management Metrics on the assigned Program.
Coaches and mentors associates as required, ensures that DM associates on the program are aware of the risks, priorities, goals and impact of the work contribution. Develops risk management strategies to prevent data quality issues from derailing projects.
Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives. Responsible for quality control and audit readiness of all assigned data management deliverables and Programs.
Provide adequate quality oversight to important tasks and activities. Ideally 8 years’ experience in Drug Development with at least 5+ years' in Clinical Data Management.
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree. Fluent English (oral and written).
Excellent understanding of clinical trials methodology, GCP and medical terminology.
Proven ability to interrogate and view data through various programming/GUI techniques.
Must be able to anticipate challenges and risks and proactively suggest/implement solutions.
Understanding of project management concepts in order to aid delivery across a program.
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
Diversity & Inclusion / EEO: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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