Remote Data Acquisition & Test Environment Specialist

Inspired Testing

Cape Town

Remote

ZAR 600,000 - 900,000

Full time

5 days ago

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Job summary

Inspired Testing is seeking a Data Acquisition Specialist - External Data (Remote/Homebased) to lead the definition, setup and ingestion of external data streams for clinical studies, including lab data, ECG, imaging and biomarkers. You will coordinate with data stakeholders to ensure proper transfer, ingestion and data structure while complying with data protection regulations.

Required: a Bachelor's in CS/related field, 3+ years in clinical data management, SDTM knowledge, data transfer

Qualifications

Bachelor's degree or equivalent, preferably in Computer Science.
Minimum of 3 years' experience managing data in support of clinical research.
Experience with external data (Safety Lab, PK, Biomarkers, ECG).
Experience with external data providers in clinical studies.
Experience developing data transfer agreements.
Experience working on clinical trials.
Experience in diverse cross-functional teams; global/multiregional.
Knowledge of SDTM.
Working knowledge of GCP/ICH guidelines.
Excellent written and verbal English.

Responsibilities

Execute deliverables for Standardized External Data Streams.
Assess external data collection requirements per protocol and plan setup activities.
Liaise with data stakeholders to establish data transfer and structure per data model.
Create change requests for new data concepts or structures.
Develop trial-specific Data Transfer Agreements documenting requirements.
Ensure data transfer frequencies meet monitoring and reporting needs.
Liaise with external data providers to align on tsDTA terms.
Translate medical concepts into data mapping guidance for Clinical programmers.
Perform UAT of test data transfers against Data Transfer Agreements.
Implement data transfer mechanisms for external streams into CDR.
Monitor availability/accuracy of external data streams and resolve issues.