Sustainability & Environment Advisor/Manager
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Data Acquisition Specialist - External Data (Remote/Homebased)
Bloemfontein, South Africa
Durban-Inland, KZN, South Africa
Centurion, South Africa
Bellville, South Africa
Full time
R
The Data Acquisition Specialist performs activities relating to the definition, set-up and ingestion of External Data Streams, and related documents and processes aligned with Clinical Trial Protocol defined requirements for data capture.
External data streams include but are not limited to typical and novel data collected through central labs and ECG, medical imaging, biomarker and genomics analysis, real world data sources, EHR, electronic patient reported outcomes, wearables and sensors and other digital data collection technologies.
- Execute deliverables for Standardized External Data Streams.
- Assess external data collection requirements per protocol and planning of external data stream set-up activities and related deliverables to meet study start-up timelines.
- Liaise with key data stakeholders to establish the purpose of data collection and requirements for the transfer, ingestion, and structure of data for each data stream in compliance with applicable data protection laws and regulations, utilizing available standards and templates
- Create change requests for the definition of new test concepts or data structures relating to external data.
- Develop trial-specific Data Transfer Agreements (tsDTA's) accurately documenting study requirements and methods for the data transfer, ingestion, and structure.
- Ensure data transfer frequencies are sufficient for the agreed requirements (medical data review, central monitoring, and reporting and analysis).
- Liaise with external data providers to ensure alignment and agreement of tsDTA.
- Translate medical and scientific concepts into data mapping guidance, per agreed data model and documented in the annotated Data Transfer Agreement for use by Clinical programmers.
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