Senior Explainer Producer: Lead, Mentor, Create

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.
• UAT of test data transfers ensure accuracy and consistency with data specifications defined in Data Transfer Agreements.
• Implement data transfer mechanisms for external data streams (into CDR) including access for external data providers.
• Monitor availability and accuracy of external data streams, liaise with external data providers to resolve data transfer issues relating to conformance of data.

Education and Experience Requirements

• Bachelor's degree or equivalent, preferably in Computer Science.
• Minimum of 3 years' experience managing data in support of clinical research.
• Experience working with external data e.g., Safety Lab, PK, Simple Biomarkers, ECG, etc
• Experience in working with external data providers within a clinical study setting.
• Experience developing data transfer agreements.
• Experience working on clinical trials.
• Experience working in highly diverse teams within clinical research; cross‑functional, global, multiregional.
• Knowledge of SDTM.
• Working knowledge of GCP/ICH guidelines
• Excellent written and verbal communication in English.

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