Hybrid Clinical Data Scientist Job at Novartis, Apply Online
Clinical Data Scientist (Multiple Roles/Clinical Data Manager)
Job ID: REQ-10029991
Date: Dec 03, 2024
Location: India
Summary
Internal Role Title: Clinical Data Scientist
Location: Hyderabad #LI-Hybrid
About the Role:
Clinical Data Scientist is responsible for using advanced data management tools and techniques to provide 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. Ensures consistently high-quality data is available for analysis and reporting.
Key Responsibilities:
- As Clinical Data Scientist, provide data management input on Clinical Trial teams. May have the role of Trial Data Scientist on small, low-complexity trials.
- Perform DM activities for the startup of a study, including preparing the eCRF, CCGs where needed, Data Quality Plan (DQP), Data Quality Plan Module (DQPM), and performing User Acceptance Testing (UAT) as applicable.
- Manage local lab setup for the Clinical Database as applicable. Under supervision, ensures consistency of assigned trials with program-level standards.
- Understand third-party data requirements and begin to gather an understanding of new technologies that may be used during clinical trials.
- Perform ongoing review of all data generated from the clinical study, including third-party and local lab data as well as SAE reconciliation where applicable.
- Ensure activities performed are done with quality and understanding of the process. Verify and track eCRF completion, including query resolution, and provide data status updates as needed. With support from the Trial Data Scientist, develop proposals to resolve issues that may occur during the running of assigned trials.
- With support from the Trial Data Scientist, provide input into Study Specification worksheets should assigned trials need to be outsourced.
- Have a working knowledge of FDA and ICH guidelines. Proven ability to use the tools available to generate listings for data review, and where necessary, provide these to the study teams. Generate study status reports for use at Clinical Trial Team meetings.
Essential Requirements:
- University or college degree in life sciences, computer science, pharmacy, nursing, or an equivalent relevant degree.
- Strong technical skills.
- Fluent English (verbal and written).
- Ideally, 3 years’ experience in Drug Development with at least 2 years in Clinical Data Acquisition & Management.
Keywords: Novartis, Clinical Data Scientist, Job, Data Management, Drug Development, Clinical Trials, Healthcare Solutions. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebo
