Micros Hospitality Systems Consultant - Implementation & Support

Adapt IT Group; Durban; Remote; ZAR 420.000 - 550.000; Vollzeit

Zusammenfassung

Adapt IT Group is seeking a Data Acquisition Specialist – External Data to manage the ingestion of external data streams for clinical studies. The role covers setup, data mapping, data transfer agreements, and coordination with external providers to ensure compliant data capture.

The candidate will translate medical concepts into data models, perform UAT on data transfers, and monitor data availability to meet study timelines across multiple sites.

Qualifikationen

• Bachelor's degree or equivalent, preferably in Computer Science.
• Minimum of 3 years' experience managing data in 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.

Aufgaben

• Execute deliverables for Standardized External Data Streams.
• Assess external data collection requirements per protocol and plan set-up activities to meet study timelines.
• Liaise with data stakeholders to establish data transfer requirements and structure for each data stream.
• Create change requests for new test concepts or data structures.
• Develop trial-specific tsDTA's documenting study requirements and data transfer methods.
• Ensure data transfer frequencies meet agreed requirements.
• Liaise with external data providers to align on tsDTA.
• Translate medical concepts into data mapping guidance for clinical programmers.
• UAT of test data transfers to ensure accuracy with data specifications.
• Implement data transfer mechanisms into the data repository.

Kenntnisse

English proficiency

Data management

SDTM knowledge

Ausbildung

Bachelor's degree in Computer Science

Jobbeschreibung

Data Acquisition Specialist – External Data (Remote/Homebased)

Location: 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.

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.
• 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.

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