Clinical Data Acquisition Specialist – Remote

Mua Insurance Acceptances (Pty) Ltd; South Africa; À distance; ZAR 420 000 - 540 000; Plein temps

Résumé du poste

The Data Acquisition Specialist - External Data role at Mua Insurance Acceptances (Pty) Ltd is based remotely in South Africa. You will define, set up and ingest external data streams for clinical trial data capture, aligning with protocol requirements and data protection standards.

You will liaise with data stakeholders to specify data transfer, ingestion, and structure, develop data transfer agreements, ensure data availability and accuracy, and support multi-regional studies with SDTM and

Qualifications

• Bachelor's degree or equivalent in Computer Science.
• Minimum of 3 years' experience managing data in support of clinical research.
• Experience with external data e.g., Safety Lab, PK, Simple Biomarkers, ECG, etc
• Experience 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.

Responsabilités

• 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.

Connaissances

Data management

English communication

SDTM knowledge

GCP/ICH knowledge

Stakeholder liaison

Formation

Bachelor's degree in Computer Science

Description du poste

The Data Acquisition Specialist - External Data role at Mua Insurance Acceptances (Pty) Ltd is based remotely in South Africa. You will define, set up and ingest external data streams for clinical trial data capture, aligning with protocol requirements and data protection standards.

You will liaise with data stakeholders to specify data transfer, ingestion, and structure, develop data transfer agreements, ensure data availability and accuracy, and support multi-regional studies with SDTM and