Senior Clinical Data Mapper

Job Summary

Major accountabilities:

• Provides data mapping leadership across assigned use cases/demands and acts as the Clinical Data Mapper Lead where needed -Demonstrates a business understanding of the use cases/demands profile to identify and assist in successful application of data operations processes.
• Manage task allocation of the Clinical Data Mapper in accordance with priorities defined by Clinical Data Operations Lead.
• Recognize and resolve conflicts in data flows or data standards decisions and be responsible to define new quality checks/ validation process to ensure data compliance.
• Participation for all aspects of the Process and Training to ensure full compliance to all applicable global regulatory requirements including data privacy and business objectives are achieved.
• Responsible and accountable to ensure consistency of assigned tasks related to data mappings, maintenance of relevant clinical data and metadata catalogs.
• Build or contribute to relevant data dictionaries, ontologies and vocabularies.
• Perform hands on activities to conduct data quality assessments.
• Supports and assists Clinical Data Mapper staff for assigned use cases/demands -Provides effective input into Data Operations initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence
• Serves as primary Data Mapper ensuring timely and quality deliverables by establishing and maintaining strong working relationships with data mapper teams, and functional lines.
• Acts as a CDISC SDTM/ADaM expert as required
• Discuss with Data Scientists to provide overview on the data mapping process and data related complexities & issues to be resolved.
• Lead independently or participate in improvement initiatives related to the development of the Clinical Pipeline technology
• Collaborate with Data Engineering team to submit advanced data mapping requirements for complex transformation within the Clinical Pipeline.
• 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 Data Operations activities and deliverables.
• No critical audit findings due to Data Mgmt -Adherence to Novartis policy and guidelines -Customer / partner/ project feedback and satisfaction

Minimum Requirements:

Work Experience:

• 5+ years of experience working with Clinical data
• Strong CDISC knowledge (SDTM/ADaM)
• Good knowledge of Clinical Data Lifecycle
• Being able to work with different standards
• Data Privacy knowledges
• Cross Cultural Experience.
• Functional Breadth.
• Experience in Agile way of working would be a plus.
• Project Management.

Skills:

• Clinical Data Management.
• Data Governance.
• Data Integrity.
• Data Operations.
• Data Quality.
• Data Privacy
• Databases.
• Project Management.
• SAS/SQL knowledge
• Python would be a plus
• Artificial Intelligence (Optional)

Languages :

• English.