Job Title: Data Operations Specialist – Clinical Data (Novartis Healthcare Pvt. Ltd.)
About the Role
You will contribute to Clinical Data Operations by supporting data management, data standards, and reporting activities across clinical trials. Under supervision, you will gain hands-on experience in data quality assessment, data mapping, and clinical data warehouse management while ensuring adherence to Novartis policies and CDISC standards.
Major Accountabilities
Demonstrate technical proficiency, scientific creativity, collaboration, and independent thought.
Provide input in writing specifications for use cases, data demands, and reports to ensure high-quality, consistent data.
Participate in User Acceptance Testing (UAT) and manage data mapping activities to maintain the Clinical Data Warehouse.
Support ongoing review of data generated from multiple sources.
Assist in the creation of data dictionaries, ontologies, and vocabularies under supervision.
Conduct hands-on data quality assessments.
Collaborate with data engineering teams to apply CDISC-based data standards consistently.
Report technical complaints and special case scenarios related to Novartis data.
Understand and work with all clinical study documents, from protocol to CSR, including Data Management and Biostatistics documents.
Contribute to communications for key initiatives.
Key Performance Indicators
Delivery of high-quality, timely, cost-efficient outputs across Clinical Data Operations.
Zero critical findings attributable to Data Operations.
Strict adherence to Novartis data policies, standards, and guidelines.
Positive feedback from customers, partners, and project teams.
Minimum Requirements
Work Experience
3–5 years’ experience in clinical trials data reporting.
Experience collaborating across teams and geographies.
Knowledge of clinical data, availability, and data quality assessments.
Exposure to Agile methodology is a plus.
Skills
Proficiency in CDISC SDTM/ADaM Mapping.
Clinical Data Management experience.
Ability to work with legacy, historical, and local data standards.
SQL (basic knowledge); Python is a plus.
Understanding of data privacy, operations, science, and databases.
Strong detail orientation.
Ability to work effectively in global teams.
Languages
English (required).
Desired Skills
Clinical Data Management
Databases & Data Entry
Data Operations & Data Science
Detail-Oriented Approach
Why Novartis?
At Novartis, we go beyond innovative science to support patients and their families. Our culture fosters collaboration, inclusivity, and purpose-driven work. Join a community of passionate people driving breakthroughs that change patients’ lives.
🔗 Learn more: Our People & Culture
Benefits & Rewards
Explore how Novartis helps you thrive personally and professionally:
🔗 Benefits & Rewards Handbook
Additional Information
Division: Biomedical Research
Business Unit: Pharma Research
Location: Hyderabad, India (Office-based)
Company / Legal Entity: IN10 (Novartis Healthcare Private Limited)
Functional Area: Research & Development
Job Type: Full-time
Employment Type: Regular
Shift Work: No
Accessibility & Accommodation
Novartis is committed to providing reasonable accommodation to individuals with disabilities. If you need support during the recruitment process or in performing the role, please email diversityandincl.india@novartis.com with your request and job requisition number.
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