Remote External Data Acquisition Specialist (Clinical Trials)

Sasol; South Africa; A distancia; ZAR 600.000 - 900.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Data Acquisition Specialist - External Data (Remote/Homebased) to define, set up and ingest external data streams for clinical trials. Coordinate data transfer agreements, data mapping and liaise with providers for timely, high-quality data delivery.

Requires a Bachelor's degree and 3+ years in data management for clinical research; global collaboration, strong English, and SDTM/GCP knowledge are essential.

Formación

• Bachelor's degree or equivalent, preferably in Computer Science.
• Minimum 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 diverse, cross-functional, global teams.
• Knowledge of SDTM.
• Working knowledge of GCP/ICH guidelines.
• Excellent written and verbal communication in English.

Responsabilidades

• Execute deliverables for Standardized External Data Streams.
• Assess external data collection requirements per protocol and plan set-up activities to meet start-up timelines.
• Liaise with key data stakeholders to establish data transfer requirements and structure in accordance with data protection laws.
• Create change requests for new data concepts or structures.
• Develop trial-specific Data Transfer Agreements documenting study requirements and methods for data transfer.
• Ensure data transfer frequencies meet study requirements for data review and reporting.
• Liaise with external data providers to align on tsDTA.
• Translate medical concepts into data mapping guidance for Clinical programmers.
• UAT of test data transfers ensuring alignment with Data Transfer Agreements.
• Implement data transfer mechanisms for external data streams (into CDR) with provider access.
• Monitor availability and accuracy of external data streams; resolve transfer issues.

Conocimientos

Data acquisition

External data streams

SDTM

GCP/ICH knowledge

Educación

Bachelor's degree in Computer Science or equivalent

Descripción del empleo

IQVIA is seeking a Data Acquisition Specialist - External Data (Remote/Homebased) to define, set up and ingest external data streams for clinical trials. Coordinate data transfer agreements, data mapping and liaise with providers for timely, high-quality data delivery.

Requires a Bachelor's degree and 3+ years in data management for clinical research; global collaboration, strong English, and SDTM/GCP knowledge are essential.