Data Acquisition Specialist - External Data (Remote)

About the role

The Data Acquisition Specialist defines, sets up and ingests external data streams and related documents and processes that align with clinical trial protocol requirements for data capture. External data includes data from central labs, ECG, medical imaging, biomarker and genomics analysis, real-world data, EHR, electronic patient-reported outcomes, wearables and sensors. The position is remote/home-based.

Key responsibilities

• Deliverables for standardized external data streams and assess collection requirements per protocol, planning set-up to meet study start-up timelines.
• Liaise with data stakeholders on the purpose, transfer, ingestion and structure of data, using standards and templates in line with data protection laws.
• Create change requests for new test concepts or data structures, and develop trial-specific Data Transfer Agreements (tsDTAs).
• Ensure data transfer frequency meets medical data review, central monitoring and reporting needs, and agree tsDTAs with external data providers.
• Translate medical and scientific concepts into data mapping guidance, documented in the annotated tsDTA for clinical programmers.
• Run UAT of test data transfers, implement data transfer mechanisms into the CDISC database (CDR) and monitor availability and accuracy of streams.

Required profile

• Bachelor's degree or equivalent, preferably in Computer Science.
• At least 3 years' experience managing data in support of clinical research.
• Experience with external data such as safety lab, PK, simple biomarkers, ECG, and with external data providers in clinical studies.
• Experience developing data transfer agreements and working on clinical trials.
• Experience in diverse, cross-functional, global, multiregional clinical research teams.
• Excellent written and verbal communication in English.

Required skills

• Knowledge of SDTM.
• Working knowledge of GCP/ICH guidelines.