Data Acquisition Specialist, External Clinical Data (Remote)

Fidelity Services Group; South Africa; Remote; ZAR 480,000 - 1,200,000; Full time

Job summary

IQVIA seeks a Data Acquisition Specialist for External Data, focusing on the definition, setup, and ingestion of external data streams in a remote/homebased role across South Africa. You will work with real-world data sources, ECG, imaging, biomarkers, EHR, and other digital data collection technologies.

Responsibilities include planning data stream setup, coordinating with data stakeholders, drafting tsDTA, ensuring compliance with data protection laws, and performing UAT to guarantee accuracy

Qualifications

• Bachelor's degree in Computer Science or related field.
• 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 developing data transfer agreements.
• Experience working on clinical trials.
• Knowledge of SDTM.
• Working knowledge of GCP/ICH guidelines.
• Excellent written and verbal communication in English.

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 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.

Skills

English communication

Data management

Clinical research

Education

Bachelor's degree in Computer Science or related field

Job description

IQVIA seeks a Data Acquisition Specialist for External Data, focusing on the definition, setup, and ingestion of external data streams in a remote/homebased role across South Africa. You will work with real-world data sources, ECG, imaging, biomarkers, EHR, and other digital data collection technologies.

Responsibilities include planning data stream setup, coordinating with data stakeholders, drafting tsDTA, ensuring compliance with data protection laws, and performing UAT to guarantee accuracy