Novartis, a leading global healthcare company, is dedicated to reimagining medicine to improve and extend lives. With a vision to be the most valued and trusted medicines company, Novartis fosters innovation and collaboration among a diverse team of smart and passionate individuals. Headquartered in Hyderabad, India, Novartis Healthcare Private Limited is known for its commitment to building an inclusive work environment.
Job Responsibilities
As a Clinical Data Scientist at Novartis, your primary responsibility will be to use advanced data management tools and techniques to ensure high-quality data management and analysis. Key responsibilities include:
- Providing data management input on clinical trial teams, acting as a Trial Data Scientist for small, low-complexity trials.
- Preparing eCRF, creating Clinical Data Quality Plans, and performing user acceptance testing.
- Managing local lab setups for clinical databases and ensuring trial consistency with program-level standards.
- Reviewing data generated during clinical studies, including third-party and local lab data, and performing SAE reconciliation.
- Managing eCRF completion, query resolution, and data status updates while adhering to quality standards.
- Supporting outsourced trial specifications and contributing to the development of study proposals.
- Using tools to generate data review listings and providing study status reports for clinical trial team meetings.
Qualifications
- University or college degree in life sciences, computer science, pharmacy, nursing, or a relevant field.
- Ideally, 3 years of experience in Drug Development with at least 2 years in Clinical Data Acquisition & Management.
- Strong technical skills and proficiency in clinical data management tools.
- Fluent in English, both written and verbal.
- Knowledge of FDA and ICH guidelines.
Skills
- Proficiency in advanced data management techniques and tools.
- Strong analytical and problem-solving skills to address data management challenges.
- Excellent communication skills for collaboration with clinical trial teams.
- Detail-oriented with a focus on maintaining data integrity and quality.
- Ability to work in a hybrid work environment with adaptability.
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