Remote Data Operations & Clinical Trials Specialist

Sanlam Limited; South Africa; Remote; ZAR 480,000 - 600,000; Full time

Benefits offered by this job

Remote work

Job summary

IQVIA is seeking a Data Acquisition Specialist - External Data (Remote/Homebased) to manage ingestion of external data streams and coordinate data transfer agreements for clinical trials. You will liaise with data stakeholders, translate concepts into mappings, and perform UAT to ensure data accuracy against specifications.

Ideal candidates possess a Bachelor's in Computer Science with 3+ years of clinical data experience, SDTM knowledge, and working knowledge of GCP/ICH guidelines.

Qualifications

• Bachelor's degree or equivalent, preferably in Computer Science.
• Minimum of 3 years' experience managing data in support of 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.
• 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 to meet timelines.
• Liaise with data stakeholders on data transfer and structure per data protection laws.
• Create change requests for new data concepts or structures.
• Develop trial-specific Data Transfer Agreements documenting data needs.
• Ensure data transfer frequencies meet study requirements.
• Coordinate with external data providers on tsDTA alignment.
• Translate data concepts into mapping guidance for Clinical programmers.
• UAT data transfers to ensure accuracy against specifications.
• Implement data transfer mechanisms for external streams into CDR.

Skills

Data management

SDTM

GCP/ICH

English communication

Cross-functional

Education

Bachelor's in Computer Science

Job description

IQVIA is seeking a Data Acquisition Specialist - External Data (Remote/Homebased) to manage ingestion of external data streams and coordinate data transfer agreements for clinical trials. You will liaise with data stakeholders, translate concepts into mappings, and perform UAT to ensure data accuracy against specifications.

Ideal candidates possess a Bachelor's in Computer Science with 3+ years of clinical data experience, SDTM knowledge, and working knowledge of GCP/ICH guidelines.