Data Acquisition Specialist - External Data (Remote/Homebased)
Core
Define, set-up, and ingest external data streams (labs, ECG, imaging, genomics, EHR, wearables) for clinical trials per protocol requirements.
Role type
Senior IC data acquisition specialist (clinical research)
Builds
Standardized external data streams and data transfer mechanisms into Clinical Data Repositories (CDR)
Domain
Clinical research / Life sciences
Required skills
Clinical trial data management, External data provider liaison, Data Transfer Agreement (tsDTA) development, Data mapping guidance creation, UAT of data transfers, SDTM knowledge, GCP/ICH guidelines, Data ingestion and transfer mechanisms
Preferred skills
Computer Science degree, Experience with Safety Lab/PK/Biomarkers/ECG data, Cross-functional global team experience
Technologies
CDR, SDTM, EHR, Wearables, Sensors, Central Labs, ECG, Medical Imaging, Genomics, Real World Data
Responsibilities
Execute deliverables for Standardized External Data Streams; Assess external data collection requirements per protocol; Liaise with key data stakeholders to establish data collection purpose and requirements; Create change requests for new test concepts or data structures; Develop trial-specific Data Transfer Agreements (tsDTA's); Ensure data transfer frequencies are sufficient; Translate medical and scientific concepts into data mapping guidance; UAT of test data transfers; Implement data transfer mechanisms for external data streams; Monitor availability and accuracy of external data streams.
Seniority
Mid-Senior, hands-on IC