Hybrid Architect: Creative Architectural Designer (Durban)

Placements24; Durban; Remote; ZAR 360,000 - 540,000; Full time

Job summary

Placements24 is seeking a Data Acquisition Specialist for External Data with remote/homebased work. You will define, set up and ingest external data streams for clinical trials, covering data transfer, mapping and governance across multiple data sources.

Ideal candidates have a Bachelor's degree in a relevant field and at least 3 years' experience in clinical data management with external data sources and regulatory compliance.

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• Minimum 3 years' data management experience in clinical research.
• Experience with external data such as Safety Lab, PK, ECG.
• Experience with data transfer and data protection compliance.

Responsibilities

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

Skills

Data management

Stakeholder liaison

Data mapping

UAT testing

Data transfer

Education

Bachelor's degree

Computer Science preferred

Job description

Data Acquisition Specialist - External Data (Remote/Homebased)

Bloemfontein, South Africa
Durban-Inland, KZN, South Africa
Centurion, South Africa
Bellville, South Africa
Full time

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