Senior Clinical System Lead

The role defines and facilitates the participant data journey, identifying participant data sources, transport methods, ingestion to client's ecosystem and mitigating potential challenges to ensure understanding, consistency and integrity of the participant data. The role will collaborate with technical and clinical teams across client's to define participant data requirements and challenges to provide short- and long-term solutions and be a subject matter expert within data management and statistics to facilitate effective data use and risk mitigation.

A key part of the study team providing technical and procedural guidance on data ingestion and chain of clinical data custody; will be front facing with CRO’s, vendors and internal teams.
• Identify participant data sources and document; creation of study data flow maps to show the clinical data journey. Input to technical data specifications for data ingestion and use at
client.
• Primary point for nonstandard data ingestion and defining the data demand with enablement teams – internal and external facing
• Define and conduct data ingestion reconciliation against data transfer specifications
• Perform Risk Assessment for study-level participant data content and provide guidance on risk mitigation. Assess that the right data is being collected and educating the study teams
• Support digital health technologies and eSource data use providing set up and technical support to the wider teams and maintaining data integrity, input to long term solution planning.
• Assess and define new and existing strategic vendors to support data ingestion and data quality; be part of the assessment team to understand vendor capabilities and limitations.
• Work closely with data enablement teams on data ingestion, harmonization, transformation, validation, and automation for the Clinical Data platform
• Be a key contributor to internal business and process improvement by ensuring compliance to latest technology and regulatory guidance. Involvement in Regeneron’s initiative implementation including digital protocol, automation, tokenisation, data optimisation, workflow definition.
• Ensure that the data governance framework is followed for participant data.

Strong knowledge of modern data management platforms and technologies, including Big Data, Lakehouse, and modern data ingestion and integration.

Must have experience with clinical data sets, EDC and non-crf data, and have strong analytical skills with the ability to work with a variety of large and complex datasets including (but not limited to) basic research datasets and clinical data.

Experience: Minimum of 4 years within clinical data management and data acquisition, preferably in the BioPharma industry. Ideal candidate will have 7+ years of experience.

Education: Bachelor’s degree in Computer Science, Data Science, Statistics, or a related field