Remote Data Acquisition Specialist – Clinical Trials

Topjobseeker.Com; East London; Remote; ZAR 420,000 - 660,000; Full time

Job summary

IQVIA, a leading global provider of clinical research services, seeks a Data Acquisition Specialist - External Data (Remote/Homebased) to define, set up and ingest external data streams for clinical trials. You will coordinate with data stakeholders, develop data transfer agreements and ensure data transfer accuracy and compliance with GCP/ICH guidelines.

Role involves collaborating across global teams, mapping data per model, and performing UAT on data transfers to meet start-up timelines.

Qualifications

• Bachelor's degree in Computer Science or equivalent.
• 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 diverse, cross-functional, global teams.
• Knowledge of SDTM.
• Working knowledge of GCP/ICH guidelines.
• Excellent written and verbal communication in English.

Responsibilities

• 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 data transfer purposes and requirements for transfer, ingestion, and structure of data for each stream as per data models.
• Create change requests for new test concepts or data structures.
• Develop trial-specific Data Transfer Agreements documenting study requirements and methods for data transfer, ingestion, and structure.
• Ensure data transfer frequencies meet the agreed requirements (medical data review, central monitoring, reporting, and analysis).
• Liaise with external data providers to align and agree tsDTA.
• Translate medical/scientific concepts into data mapping guidance per agreed data model and recorded in DTA for Clinical programmers.
• UAT of test data transfers ensuring accuracy with Data Transfer Agreements.

Skills

English communication

Data mapping guidance

SDTM knowledge

GCP/ICH knowledge

Education

Bachelor's degree in Computer Science or related

Job description

IQVIA, a leading global provider of clinical research services, seeks a Data Acquisition Specialist - External Data (Remote/Homebased) to define, set up and ingest external data streams for clinical trials. You will coordinate with data stakeholders, develop data transfer agreements and ensure data transfer accuracy and compliance with GCP/ICH guidelines.

Role involves collaborating across global teams, mapping data per model, and performing UAT on data transfers to meet start-up timelines.