Specialist, External Data Acquisition and Delivery
Core
Manage non-Case Report Form data delivery and ensure data integrity for clinical studies.
Role type
Specialist, Clinical Data Management
Builds
External data delivery for clinical development units
Domain
Biopharmaceuticals / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
external clinical data acquisition, data reconciliation, Data Transfer Specifications, 21 CFR Part 11, ICH-GCP, CDISC standards, SAS, CSV, XML, EDC platforms
Preferred skills
biomarker data, eCOA, imaging, ECG, PK, genomics, laboratory data
Responsibilities
Manage end-to-end non-Case Report Form data delivery, Develop low-complexity Data Transfer Specifications, Reconcile external vendor data with clinical database outputs, Track specification status across data types and programmes, Support data structure issue resolution and change requests, Maintain documentation, audit trails and inspection readiness standards
Seniority
Specialist, individual contributor
