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Novartis is a global healthcare company focused on discovering and developing innovative medicines that help improve and extend people’s lives. Its research and development work spans cardiovascular, renal and metabolic diseases, immunology, neuroscience, and oncology, combining scientific collaboration with modern technology platforms. The company also emphasizes diversity, equity and inclusion, alongside social and environmental responsibility, as part of its work in advancing medicine.
Senior Clinical Data Scientist at Novartis
Lead clinical data management, quality, and regulatory deliverables for Novartis trials. Coordinate study teams, data reviews, testing, and process improvements from the Hyderabad or Mumbai offices.
Description
- Deliver Data Management products and milestones efficiently for assigned clinical trials.
- Lead Data Management across assigned trials and serve as Trial Data Manager when needed.
- Apply knowledge of compound profiles to support Data Management processes.
- Review protocols and amendments and provide feedback.
- Resolve protocol issues that affect database design, data validation, analysis, or reporting.
- Complete study start-up Data Management work, including Data Handling Plans, Data Review Plans, and user acceptance testing.
- Set up local laboratories for clinical databases where applicable.
- Lead process and training deliverables for platforms or processes.
- Meet global regulatory requirements and business objectives.
- Coordinate data operations for audits and inspections.
- Manage quality issues, exception requests, deviations, and corrective and preventive action plans.
- Carry out hands-on Data Management work throughout each study.
- Review clinical study data, including third-party and local laboratory data and SAE reconciliation where applicable.
- Align assigned trials with program-level Data Management standards and documentation.
- Prepare data-review listings for study teams as needed.
- Prepare study status reports for clinical trial team meetings.
- Support junior staff on assigned trials.
- Contribute to Data Management initiatives focused on innovation, quality, efficiency, continuous improvement, scientific excellence, and operational excellence.
- Lead or coordinate synonym reviews and dictionary version upgrades at trial or program level.
- Serve as primary study lead, building strong relationships with study teams and functional lines to deliver work on time and to quality standards.
- Provide technical consulting as required.
Requirements
- Work effectively under pressure and demonstrate agility through effective, innovative team leadership.
- Bring excellent interpersonal skills and the ability to operate effectively in a global environment.
- Influence and communicate across functions and with external stakeholders.
- Demonstrate the ability to interrogate and view data using programming or GUI techniques.
- Have excellent problem-solving skills.
- Ideally have four years of Drug Development experience, including at least three years in Clinical Data Management.
- Have excellent verbal and written communication skills.
- Know Clinical Data Management, Data Governance, Data Integrity, Data Management, Data Quality, Data Science, and the Waterfall Model.
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