We are seeking a Senior Clinical Data Scientist to assist/lead in the timely and professional management of clinical trial data using advanced data management tools and techniques, providing professional and lean execution of Data Management products and milestones with respect to cost, quality, and timelines for all assigned trials within Clinical Data Acquisition and Management.
This role reports to the Director Data Management.
About the RoleKey Responsibilities: Provides DM leadership across assigned trial(s) and acts as the Trial Data Scientist where needed, ensuring strong DM representation across the CTT for moderate complexity non-priority trial(s).Demonstrates a business understanding of the compound(s) profile and data strategy to identify and assist in successful application of data management processes and documentation across assigned trials, ensuring consistency across data quality plans.Ensures alignment with the TA level data strategy as defined by the TA Data Strategy Director.Understanding of CDISC or other recognized industry standards and how these impact the programming team.Provides accelerated feedback to assure well written, stable protocols and amendments. Recognizes and resolves protocol issues that may impact database design, data validation, and/or analysis/reporting, minimizing the data footprint to focus on the trial endpoints and ensuring utilization of available data standards.Performs DM activities for study start-up including preparing the architecture of the eCRF, CCG's, Data Quality Plan (DQP), Data Quality Plan Module (DQPM), Data Transfer Specification (DTS), and performing user acceptance testing (UAT).Manages local lab set-up for the Clinical Database as applicable.Performs DM hands-on activities during the course of the study, with a strong emphasis on quality, integrity, and on-time delivery.Qualifications: University or college degree in life science, computer science, pharmacy, nursing, or equivalent relevant degree.Fluent in English (oral and written).Ability to work under pressure demonstrating agility through effective and innovative team leadership.Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders.Proven ability to interrogate and view data through various programming/GUI techniques.Excellent problem-solving skills.Ideally 5+ years' experience in Drug Development with at least 4 years in Clinical Data Management.Excellent verbal and written communication skills.Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives, and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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