Offer summary

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 and clinical trials., Excellent written and verbal communication in English..

Key responsibilities:

Define, set-up, and ingest External Data Streams aligned with Clinical Trial Protocol requirements.

Collaborate closely with Data Managers, Study Responsible Physicians, and Study Responsible Scientists.

Manage activities related to data capture from various external sources including Electronic Health Records and digital health technologies.

Develop data transfer agreements and ensure compliance with GCP/ICH guidelines.

Job description

eSOURCE Data Acquisition Expertise. The Data Acquisition Expert 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. Activities are conducted in close collaboration with Data Managers, Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS).
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, Electronic Health records, electronic patient reported outcomes, wearables and sensors and other digital data collection technologies.

Base Level:
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, or similar.
Experience working on clinical trials.
Experience working in highly diverse teams within clinical research; cross-functional, global, multiregional.
Working knowledge of SDTM.
Working knowledge of GCP/ICH guidelines
Excellent written and verbal communication in English.
Demonstrated experience in working with external data providers within a clinical study setting.
Experience developing data transfer agreements.
Experience working with novel external data e.g., Real world data, digital health technologies, Electronic Health records (HL7, FIHR) or similar.

Advanced Level – see base level + relevant modifications below:

Minimum of 5 years’ experience managing data in support of clinical research.
Experience working with complex external data e.g., Biomarkers, Genomics, imaging or similar.
Demonstrated project management skills.
Experience working with novel external data e.g., Real world data, digital health technologies, Electronic Health records (HL7, FIHR) or similar.

This role is not eligible for UK visa sponsorship

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 https://jobs.iqvia.com

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