Registry Clerk

EdUpStairs; Pretoria; Remote; ZAR 420,000 - 660,000; Full time

Job summary

IQVIA is seeking a Data Acquisition Specialist - External Data (Remote/Homebased) to lead the definition, setup and ingestion of external data streams for clinical trials. The role collaborates with cross-functional teams to map and transfer data from sources such as labs, ECG, biomarkers, EHR and wearables, ensuring compliance with data protection laws and SDTM standards.

You will develop data transfer agreements, coordinate with external providers and perform UAT to ensure accuracy of data

Qualifications

• 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, ECG.
• Experience with external data providers in a clinical study setting.
• Experience developing data transfer agreements.
• Experience working on clinical trials and diverse teams.
• Knowledge of SDTM and working knowledge of GCP/ICH.

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 requirements.
• Create change requests for new data concepts or data structures.
• Develop trial-specific Data Transfer Agreements documenting requirements and methods.
• Ensure data transfer frequencies meet agreed requirements.
• Liaise with external data providers to align tsDTA.
• Translate concepts into data mapping guidance for Clinical programmers.
• UAT of test data transfers to ensure accuracy with Data Transfer Agreements.
• Implement data transfer mechanisms for external data streams (into CDR).
• Monitor availability and accuracy of external data streams and resolve issues.

Skills

Data management

External data handling

Data mapping

SDTM

GCP/ICH

English communication

Education

Bachelor's degree in Computer Science

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 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. Learn more at is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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