Job Description

### Summary

• Assist in the timely & professional ongoing Mgmt of data Operations on Use Cases/Demand deliverables and of clinical data warehouse maintenance with respect to cost, quality and timelines within Clinical Pipeline team. Ensure high quality data available for secondary analysis use. Support content development and upgrade to training modules into engaging and interactive applications. Follows data regulations and laws, data-handling procedures and data mapping guidelines. Supports quality deliverables within Clinical Data Operations (DO). Manage data Load, Transfer from Novartis Clinical Data Lake and conform of Clinical trial data to SDTM/ADaM compliant standards within the Clinical Data Warehouse. Supports the delivery of quality data, processes and documentation contributor role in ensuring that use case/demands are executed efficiently with timely and high quality deliverables.


### About the Role

Major accountabilities:

• Demonstrates potential for technical proficiency, scientific creativity, collaboration with others and independent thought.
• Under supervision provides input into writing specifications for use cases/demand and necessary reports to ensure high quality and consistent data -Involved in User acceptance testing (UAT) and managing data mapping activities to maintain Clinical Data Warehouse -Under supervision, participates in ongoing review of all data generated from different sources -Supports the development of communications for initiatives.
• Perform hands on activities to conduct data quality assessments.
• Creates under supervision and learns relevant data dictionaries, ontologies and vocabularies -Reporting of technical complaints / special case scenarios related to Novartis data
• Collaborate with other data engineering teams to ensure consistent CDISC based data standards applied
• Be familiar with all clinical study documents from protocol to CSR including Data Management and Biostatistic documents.

Key performance indicators:

• Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across Clinical Data Operations activities & deliverables.
• No critical data findings due to Data Operations-Adherence to Novartis policy, data standards and guidelines -Customer / partner/ project feedback and satisfaction

Minimum Requirements:

Work Experience:

• 3-5 years of experience in working in clinical trials data reporting
• Collaborating across boundaries.
• Knowledge of clinical data
• Availability of sufficient information to find and understand data
• Availability of data quality assessments
• Experience in Agile way of working would be a plus

Skills:

• CDISC SDTM/ADaM Mapping
• Clinical Data Management.
• Experience in being able to work with different legacy, historical, local data standards
• SQL basic knowledges
• Python skills would be a plus
• Able to work in a worldwide team
• Data Privacy
• Data Operations.
• Data Science.
• Databases.
• Detail Oriented.

Languages :

• English.

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Division
Biomedical Research
Business Unit
Innovative Medicines
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No

### Accessibility and accommodation


Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.


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