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Expert Clinical Data Scientist

Expert Clinical Data Scientist

NOVARTIS

2 - 8 years

20 - 25 Lacs

Hyderabad

Posted:1 month ago| Platform:

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Skills Required

Data validation Data management Coding GCP Database design Reconciliation Clinical research Data quality User acceptance testing Clinical data management

Work Mode

Work from Office

Job Type

Full Time

Job Description

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. 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.

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NOVARTIS

Pharmaceutical Manufacturing

Basel Baselstadt

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Expert Clinical Data Scientist