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 :
