Data Acquisition Specialist External Data (Remote UK)

The Data Acquisition Specialist 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.

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 EHR electronic patient reported outcomes wearables and sensors and other digital data collection technologies.

Deliverables

• Execute deliverables for Standardized External Data Streams.

• Assess external data collection requirements per protocol and planning of external datastream set-up activities and related deliverables to meet study start-up timelines.

• Liaise with key data stakeholders to establish the purpose of data collection andrequirements for the transfer ingestion and structure of data for each data stream incompliance with applicable data protection laws and regulations utilizing availablestandards and templates

• Create change requests for the definition of new test concepts or data structures relating toexternal data.

• Develop trial-specific Data Transfer Agreements (tsDTAs) accurately documenting studyrequirements and methods for the data transfer ingestion and structure.

• Ensure datatransfer frequencies are sufficient for the agreed requirements (medical data review centralmonitoring and reporting and analysis).

• Liaise with external data providers to ensure alignment and agreement of tsDTA.

• Translate medical and scientific concepts into data mapping guidance per agreed datamodel and documented in the annotated Data Transfer Agreement for use by Clinicalprogrammers.

• UAT of test data transfers ensure accuracy and consistency with data specifications definedin Data Transfer Agreements.

• Implement data transfer mechanisms for external data streams (into CDR) including accessfor external data providers.

• Monitor availability and accuracy of external data streams liaise with external dataproviders to resolve data transfer issues relating to conformance of data.

Education and Experience Requirements

• Bachelors 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 etc

• Experience in working with external data providers within a clinical study
  setting.

• Experience developing data transfer agreements.

• Experience working on clinical trials.

• Experience working in highly diverse teams within clinical research; cross-functional global multiregional.

• Knowledge of SDTM.

• Working knowledge of GCP/ICH guidelines

• Excellent written and verbal communication in English.

This role is not eligible for UK visa sponsorship

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