External Bursar Learner

Sibanye Stillwater; Rustenburg; Remote; ZAR 450.000 - 650.000; Vollzeit

Zusammenfassung

IQVIA seeks a Data Acquisition Specialist - External Data (Remote/Homebased) to define, set up and ingest external data streams for clinical studies. You will collaborate with labs, ECG, imaging, EHR and other sources, ensuring compliant transfer and accurate data mapping for downstream analytics.

The role requires a Bachelor’s in CS (or equivalent) and at least 3 years in clinical data management, with strong English communication and knowledge of SDTM, GCP/ICH guidelines.

Qualifikationen

• Bachelor’s degree in Computer Science or equivalent is required.
• Minimum 3 years of experience managing data in clinical research.
• Experience with external data sources (labs, ECG, imaging, EHR) is preferred.
• Knowledge of data protection regulations and data transfer concepts.

Aufgaben

• Define, set up and ingest External Data Streams per protocol requirements.
• Liaise with data stakeholders and external providers for data transfer and tsDTA agreements.
• Translate medical concepts into data mapping guidance for Clinical programmers.
• UAT testing and monitoring of external data transfers for accuracy.

Kenntnisse

English communication

SDTM knowledge

GCP/ICH knowledge

Cross-functional teamwork

Data ingestion

Ausbildung

Bachelor's degree in Computer Science or equivalent

Jobbeschreibung

Data Acquisition Specialist - External Data (Remote/Homebased)

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.

Deliverables

• 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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