Novartis

Job Description Summary

Internal Role Title: Expert Clinical Data Scientist

Location: Mumbai & Hyderabad #LI-Hybrid

About the Role:

We are seeking a highly skilled Expert Clinical Data Scientist to provide timely and professional management of data management, coding, CDDRA-database development, and DAP deliverables for clinical trial data. The successful candidate will ensure high-quality data is available for analysis and reporting, develop engaging training modules, and leverage technology for process simplification and training delivery. This role requires adherence to Good Clinical Practices (GCP), data-handling procedures, and guidelines, and involves participation in the review of clinical research protocols, reports, and statistical analysis plans.

Job Description

Key Responsibilities: -

• Provide leadership across assigned trials and act as the Trial Data Manager when needed, demonstrating a business understanding of the compound profiles.
• Manage data load, transfer, and conformance of clinical trial data to NCDS compliant standards, ensuring timely and high-quality deliverables.
• Perform data management activities for study start-up, including data handling plans, data review plans, and user acceptance testing (UAT).
• Lead process and training deliverables within the platform or processes, ensuring compliance with global regulatory requirements and achieving business objectives.
• Conduct ongoing review of all data generated from clinical studies, including third-party and local lab data, and perform SAE reconciliation where applicable.
• Generate study status reports for use at clinical trial team meetings and support junior staff for assigned trials.
• Lead DAP activities for assigned project-level activities for phase I to IV clinical studies and participate in improvement initiatives and nonclinical projects.

Essential Requirements: -

• Proven experience in clinical data management, data governance, data integrity, and data quality.
• Strong project management skills with the ability to manage multiple tasks and projects simultaneously.
• Cross-cultural experience and functional breadth in managing clinical data management activities.
• Ability to recognize and resolve protocol issues that may impact database design, data validation, and analysis/reporting.
• Excellent communication and interpersonal skills to establish and maintain strong working relationships with study teams and functional lines.
• Proficiency in using data management tools to generate listings for data review and provide these to study teams.

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! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Skills Desired

Clinical Data Management, Databases, Data Governance, Data Integrity, Data Management, Data Quality, Data Science, Waterfall Model