Lab & Workplace Experience Student: Grow & Learn

Tiger Consumer Brands Ltd.; South Africa; Remote; ZAR 420,000 - 780,000; Full time

Job summary

IQVIA is seeking a Data Acquisition Specialist - External Data to define, set up and ingest external data streams for clinical studies. You will work remotely with global teams to structure data transfer and coordination with providers.

The role requires 3+ years in clinical data management, knowledge of SDTM and GCP/ICH, and strong English communication. UAT, data mapping, and tsDTA development are key aspects of the job.

Qualifications

• 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 (Safety Lab, PK, Biomarkers, ECG).
• Experience with external data providers in a clinical study setting.
• Experience developing data transfer agreements.
• Experience working on clinical trials.
• Experience in diverse, cross-functional teams.
• Knowledge of SDTM and GCP/ICH guidelines.
• Excellent written and verbal English communication.

Responsibilities

• Execute deliverables for Standardized External Data Streams.
• Assess external data collection requirements per protocol and plan setup activities.
• Liaise with data stakeholders to define data transfer and structure per data model.
• Create change requests for new data concepts or structures.
• Develop tsDTA documents detailing data transfer requirements.
• Ensure data transfer frequencies meet study needs.
• Collaborate with external data providers for alignment on tsDTA.
• Translate scientific concepts into data mapping guidance for programmers.
• UAT of test data transfers for accuracy with specifications.
• Implement data transfer mechanisms for external streams into CDR.
• Monitor data availability and resolve transfer issues with providers.

Skills

Data management

Clinical research

Communication

GCP/ICH knowledge

SDTM knowledge

Data transfer agreements

Stakeholder liaison

Education

Bachelor's degree (Computer Science preferred)

Tools

EDC systems

Data mapping tools

SQL

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.

• 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.

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