Impact-Driven Sustainability & Environment Lead

Maraen; South Africa; Remote; ZAR 360,000 - 600,000; Full time

Job summary

Maraen in South Africa is seeking a Data Acquisition Specialist - External Data (Remote/Homebased) to define, set up and ingest external data streams for clinical trial data capture, including lab results, ECG, imaging and real world data sources.

You will liaise with data stakeholders, create data transfer agreements, map data concepts to the clinical data model, ensure timely transfers and perform user acceptance testing.

Responsibilities

• 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.
• UAT of

Job description

Maraen in South Africa is seeking a Data Acquisition Specialist - External Data (Remote/Homebased) to define, set up and ingest external data streams for clinical trial data capture, including lab results, ECG, imaging and real world data sources.

You will liaise with data stakeholders, create data transfer agreements, map data concepts to the clinical data model, ensure timely transfers and perform user acceptance testing.