Bi Analyst: Insightful Dashboards & Data Modelling

Cf Consulting; Cape Town; Remote; ZAR 600,000 - 900,000; Full time

Job summary

Cf Consulting is seeking a Data Acquisition Specialist - External Data (Remote/Homebased) to define, set-up and ingest External Data Streams for clinical trials. You will coordinate with laboratories, ECG, biomarkers, EHR and other data sources and ensure compliant data transfer and mapping.

The role requires a Bachelor’s degree and at least 3 years’ experience in clinical data management, SDTM knowledge, and familiarity with GCP/ICH guidelines.

Qualifications

• Bachelor's degree or equivalent; preferably in Computer Science.
• Minimum of 3 years' experience managing data in clinical research.
• Experience with external data sources (lab, ECG, biomarkers, EHR, wearables).
• Experience developing data transfer agreements and cross-functional collaboration.
• Knowledge of SDTM and working knowledge of GCP/ICH guidelines.

Responsibilities

• Define, set-up and ingest External Data Streams per protocol.
• Liaise with data stakeholders to establish data transfer requirements.
• Create change requests for new data concepts or structures.
• Develop trial-specific data transfer agreements documenting study requirements.
• Ensure data transfer frequencies meet study needs.
• Coordinate with external data providers to align tsDTA.
• Translate concepts into data mapping guidance for programmers.
• UAT of test data transfers to ensure alignment with specifications.
• Implement data transfer mechanisms for external streams into the system.
• Monitor availability and accuracy of external data streams and resolve data issues.

Skills

Data management

Clinical data

Communication

Education

Bachelor's degree in Computer Science

Tools

SDTM

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
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 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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