Associate Clinical Data Scientist (Novartis)

Roles and Responsibilities

Major Accountabilities

~ Demonstrates potential for technical competence, scientific creativity, collaboration, and independent thinking.
~ Begins developing practical knowledge of the Clinical Trial Protocol (CSP), Data Treatment Plan (DHP), and Data Review Plan (DRP), or an equivalent plan, and contributes to these.
~ Under supervision, provides input into writing specifications for study-specific validation tests and necessary reports to ensure high-quality and consistent data.
~ Participates in User Acceptance Testing (UAT) and administration of the local laboratory set up for the clinical database, where applicable.
~ Under supervision, participates in the ongoing review of all data from the clinical trial, including third-party and local laboratory data, and SAE reconciliation, where applicable.
~ Supports process and training outcomes within the platform or processes.
~ Supports the development of communications for initiatives.
~ Creates graphics for training and operational applications under supervision and learns new media.
~ Participates in PSC activities for quality compliance, audit readiness, and CAPAs
. ~ Participates in QC activities driven by PSC to ensure high-quality results.
~ Ensures identified deviations are reported to the Group CEO.
~ Ensures activities are performed with quality and process understanding.
~ Assists in tracking and reporting the status of assigned tasks and ensures appropriate tracking systems are up-to-date and accurate.
~ Performs accurate and consistent coding, managing coding
. ~ Conducts related queries as needed under supervision. Develops an understanding of coding tools and dictionaries. Serves in a supportive role under the direction of a project or study manager on studies by establishing and maintaining working relationships with Data Operations. Ensures clinical systems for assigned studies comply with regulatory requirements and internal standards are applied with quality. Participation in improvement initiatives and/or non-clinical projects.
~ Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
~ Distribution of marketing samples (if applicable).

Key Performance Indicators
Support the timely and professional ongoing management of data change/coding results and clinical database delivery/DAP data regarding costs, quality, and timelines for assigned studies managed within Clinical Data Management. Ensure high-quality data is available for analysis and reporting. Support the development of content and the updating of training modules for engaging and interactive applications. Adhere to Good Clinical Practices (GCP), data processing procedures, and guidelines. Support high-quality results within Data Operations (DO). Support the delivery of quality data and programs, processes, and documentation. Contribute to the
efficient, timely, and high-quality execution of drug development plans within Novartis Global Drug Development.