External Data Management Specialist
Core
Supports trial-level external-data activities by authoring transfer specifications, coordinating with service providers/IT for data ingestion, and performing completeness, reconciliation, and traceability checks.
Role type
Senior IC clinical data management specialist (external data)
Builds
External data specifications, transfer logs, and review-ready datasets for Clinical Data Management (CDM)
Domain
Clinical trials / Life Sciences
Required skills
Clinical trial data structures, EDC systems, CDISC standards (SDTM, CDASH), controlled vocabularies (LOINC), data integration defect patterns, mapping rules, load log analysis
Preferred skills
Nursing, Pharmacy, Life Sciences, Information Technology, Data Science, Medical Technology
Technologies
EDC, eCOA, eTMF, CDISC, LOINC
Responsibilities
Gather external data requirements from protocols and stakeholders; Develop external data specifications; Execute test and production file reviews; Monitor file loads and resolve errors; Support specimen lifecycle reconciliation; Participate in service provider governance forums; Monitor KPIs and communicate risks; Support quality assurance audits and CAPA resolution; Maintain documentation in eTMF per SOPs.
Seniority
Mid-Senior, hands-on IC
