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.

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.

Skills Desired
Clinical Data Management, Databases, Data Entry, Data Management, Data Science, Detail-Oriented
Skills Desired Analytical Skill, Computer Programming, Computer Science, Data Science

Skills Required